Trial Outcomes & Findings for Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia (NCT NCT02890329)
NCT ID: NCT02890329
Last Updated: 2026-04-29
Results Overview
Defined as the highest dose at which 1 or fewer of 6 patients experience a dose limiting toxicity graded by Common Terminology Criteria for Adverse Events version 5.0 criteria.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Monitoring for DLTs occurs continuously on treatment during the first 8 weeks of combination therapy (56 days from the start of combination) during the induction phase only.
Results posted on
2026-04-29
Participant Flow
Participant milestones
| Measure |
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 0
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 0
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 1
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 1
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 2
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 2
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
|---|---|---|---|---|---|---|
|
Cohort 1: Dose Level 0 (3 mg/kg Ipi)
STARTED
|
8
|
6
|
0
|
0
|
0
|
0
|
|
Cohort 1: Dose Level 0 (3 mg/kg Ipi)
COMPLETED
|
7
|
4
|
0
|
0
|
0
|
0
|
|
Cohort 1: Dose Level 0 (3 mg/kg Ipi)
NOT COMPLETED
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 1 (5 mg/kg Ipi)
STARTED
|
0
|
0
|
4
|
5
|
0
|
0
|
|
Cohort 2: Dose Level 1 (5 mg/kg Ipi)
COMPLETED
|
0
|
0
|
3
|
3
|
0
|
0
|
|
Cohort 2: Dose Level 1 (5 mg/kg Ipi)
NOT COMPLETED
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Cohort 3: Dose Level 2 (10 mg/kg Ipi)
STARTED
|
0
|
0
|
0
|
0
|
15
|
16
|
|
Cohort 3: Dose Level 2 (10 mg/kg Ipi)
COMPLETED
|
0
|
0
|
0
|
0
|
15
|
16
|
|
Cohort 3: Dose Level 2 (10 mg/kg Ipi)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 0
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 0
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 1
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 1
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 2
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 2
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
|---|---|---|---|---|---|---|
|
Cohort 1: Dose Level 0 (3 mg/kg Ipi)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Cohort 1: Dose Level 0 (3 mg/kg Ipi)
Progression during lead-in decitabine cycle
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 1 (5 mg/kg Ipi)
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Cohort 2: Dose Level 1 (5 mg/kg Ipi)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 0
n=8 Participants
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 0
n=6 Participants
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 1
n=4 Participants
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 1
n=5 Participants
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 2
n=15 Participants
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 2
n=16 Participants
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.5 years
n=9 Participants
|
74.5 years
n=24 Participants
|
64.5 years
n=23 Participants
|
75 years
n=73 Participants
|
66 years
n=451 Participants
|
74.5 years
n=60 Participants
|
71 years
n=162 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
9 Participants
n=451 Participants
|
5 Participants
n=60 Participants
|
24 Participants
n=162 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
5 Participants
n=73 Participants
|
6 Participants
n=451 Participants
|
11 Participants
n=60 Participants
|
30 Participants
n=162 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=73 Participants
|
1 Participants
n=451 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=162 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
4 Participants
n=73 Participants
|
14 Participants
n=451 Participants
|
15 Participants
n=60 Participants
|
51 Participants
n=162 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=451 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=162 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=162 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=162 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=162 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=162 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
4 Participants
n=73 Participants
|
13 Participants
n=451 Participants
|
16 Participants
n=60 Participants
|
51 Participants
n=162 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=162 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=73 Participants
|
2 Participants
n=451 Participants
|
0 Participants
n=60 Participants
|
3 Participants
n=162 Participants
|
|
ECOG Performance Status
0 (Asymptomatic and fully active)
|
5 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=451 Participants
|
3 Participants
n=60 Participants
|
9 Participants
n=162 Participants
|
|
ECOG Performance Status
1 (Symptomatic; fully ambulatory; restricted in physically strenuous activity)
|
3 Participants
n=9 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
5 Participants
n=73 Participants
|
13 Participants
n=451 Participants
|
11 Participants
n=60 Participants
|
42 Participants
n=162 Participants
|
|
ECOG Performance Status
2 (Symptomatic; ambulatory; capable of self-care greater than 50% waking hours)
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=451 Participants
|
2 Participants
n=60 Participants
|
3 Participants
n=162 Participants
|
|
Histology
AML
|
7 Participants
n=9 Participants
|
5 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
5 Participants
n=73 Participants
|
14 Participants
n=451 Participants
|
9 Participants
n=60 Participants
|
44 Participants
n=162 Participants
|
|
Histology
MDS
|
1 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=451 Participants
|
7 Participants
n=60 Participants
|
10 Participants
n=162 Participants
|
PRIMARY outcome
Timeframe: Monitoring for DLTs occurs continuously on treatment during the first 8 weeks of combination therapy (56 days from the start of combination) during the induction phase only.Population: Patients who received combination ipilimumab and decitabine.
Defined as the highest dose at which 1 or fewer of 6 patients experience a dose limiting toxicity graded by Common Terminology Criteria for Adverse Events version 5.0 criteria.
Outcome measures
| Measure |
Arm A (Decitabine, Ipilimumab), Post Allo-HCT
n=25 Participants
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive
n=23 Participants
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
|---|---|---|
|
Maximum Tolerated Dose (Recommended Phase 2 Dose) of Ipilimumab in Combination With Decitabine
|
10 mg/kg
|
10 mg/kg
|
SECONDARY outcome
Timeframe: Up to 52 weeksWill be assessed by 2003 International Working Group response criteria for acute myeloid leukemia and 2006 International Working Group criteria for myelodysplastic syndrome. For acute myeloid leukemia, overall response rate includes complete remission + complete remission with incomplete count recovery; for myelodysplastic syndrome, overall response rate includes complete remission + marrow complete remission + partial remission + hematologic improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from registration to the earlier of progression or death due to any cause, assessed up to 52 weeksWill be assessed by 2003 International Working Group criteria for acute myeloid leukemia and 2006 International Working Group criteria for myelodysplastic syndrome. Time to event summaries will use the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from registration to death due to any cause or censored at the date last known alive, assessed up to 52 weeksWill be assessed by 2003 International Working Group criteria for acute myeloid leukemia and 2006 International Working Group criteria for myelodysplastic syndrome. Time to event summaries will use the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 100 daysWill be separately evaluated in patients in the post-allogeneic hematopoietic stem cell transplant cohort, and compared to events with response to treatment. Graft-versus-host disease for the patients on the post-transplant arm will be estimated and reported with a 90% exact binomial confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 weeksWill be separately evaluated in patients in the post-allogeneic hematopoietic stem cell transplant cohort, and compared to events with response to treatment. Graft-versus-host disease for the patients on the post-transplant arm will be estimated and reported with a 90% exact binomial confidence interval.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to cycle 3 day 1Absolute lymphocyte count levels will be measured prior to treatment and after cycle 2. ALC changes (from baseline to cycle 2) will be compared between responders and non-responders.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 0
Serious events: 4 serious events
Other events: 7 other events
Deaths: 7 deaths
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 0
Serious events: 3 serious events
Other events: 4 other events
Deaths: 6 deaths
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 4 deaths
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 5 deaths
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 2
Serious events: 12 serious events
Other events: 15 other events
Deaths: 9 deaths
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 2
Serious events: 13 serious events
Other events: 16 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 0
n=7 participants at risk
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 0
n=4 participants at risk
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 1
n=3 participants at risk
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 1
n=3 participants at risk
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 2
n=15 participants at risk
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 2
n=16 participants at risk
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
28.6%
2/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
66.7%
2/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
100.0%
3/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
26.7%
4/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
43.8%
7/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Heart failure
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
66.7%
2/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Endocrine disorders
Hypoadrenalism
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
Pre-septal cellulitis/Dacroadentitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
Septal cellultiis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
C. diff infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
26.7%
4/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Esophageal stricutre
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Rectal Fisula
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Death NOS
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Disease progression
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Edema limbs
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Failure to thrive
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Fatigue
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Fever
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Immune system disorders
Oral GVHD
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Immune system disorders
aGvHD
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Bone infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Candidemia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Central line
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
EBV reactivation
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Epstein-Barr Virus
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Lung infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Otitis media
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Pnemonia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Soft tissue infection
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Strep mitis bacteria, pneumonia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Thenoorchitis epididymitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Thenorchitis epidyditmitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Wound infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
GGT increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Lipase increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Stroke
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Confusion
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Reproductive system and breast disorders
Breast Pain
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
66.7%
2/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Leukemia Cutis LLE
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Leukemia cutis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Hematoma
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
acute on chronic subdural hematoma
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Endocrine disorders
Blood Lactate Dehydrogenase increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
Other adverse events
| Measure |
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 0
n=7 participants at risk
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 0
n=4 participants at risk
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (3 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 1
n=3 participants at risk
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 1
n=3 participants at risk
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (5 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm A (Decitabine, Ipilimumab), Post Allo-HCT, Dose Level 2
n=15 participants at risk
PRIMING PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Post allo-HCT patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
Arm B (Decitabine, Ipilimumab), Transplant Naive, Dose Level 2
n=16 participants at risk
PRIMING PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 out of 28 days.
INDUCTION PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Transplant naive patients receive decitabine IV over 60 minutes on days 1-5 and ipilimumab IV (10 mg/kg) over 90 minutes on day 1. Treatment repeats every 4 or 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Ipilimumab: Given IV
|
|---|---|---|---|---|---|---|
|
General disorders
Muscle spasms
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Night sweats
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Non-cardiac chest pain
|
42.9%
3/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Nose bleed
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Rothia Mucilaginosa PICC line colonization
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Transfusion reaction
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Hepatobiliary disorders
gallstones
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Immune system disorders
Allergic reaction
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Immune system disorders
GI GVHD
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Immune system disorders
Liver GVHD
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Immune system disorders
Oral GVDH
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Immune system disorders
Oral GVHD
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Immune system disorders
Skin GVHD
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Clostridium difficile
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Cytomegalovirus reactivation
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
EBV Reactivation
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Epstein-Barr Virus
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Lung infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Pleural infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Thrush
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Yeast infection
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
neutropenic fever
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
66.7%
2/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Burn
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Dog bite
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Gum bleeding
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Adrenal necrosis/Inflammatory Infiltrate
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
GGT increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
31.2%
5/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
2/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
8/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Blood bicarbonate dec.
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Blood bicard decreased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Creatinine increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
37.5%
6/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
INR increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Lipase increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Lymphocyte count decreased
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
75.0%
3/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
37.5%
6/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
75.0%
3/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
60.0%
9/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
8/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Platelet count decreased
|
28.6%
2/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
100.0%
3/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
40.0%
6/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
43.8%
7/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Serum amylase increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Weight gain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Weight loss
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
31.2%
5/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
White blood cell decreased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
46.7%
7/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
43.8%
7/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
increased myelofibrosis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
53.3%
8/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
37.5%
6/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Glucosuria
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
56.2%
9/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
5/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
37.5%
6/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
37.5%
6/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp (R Hand)
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp (R leg)
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
R achilles pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
muscle cramp (L leg)
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
muscle cramping
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
L3 Lumbar lesion
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Concentration impairment
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
75.0%
3/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Confusion
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Reproductive system and breast disorders
Left breast lesion
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Lymphedema
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
66.7%
2/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
26.7%
4/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
2/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
56.2%
9/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
31.2%
5/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
26.7%
4/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Erythema at PICC
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Erythema; back
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Pruritic
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
2/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
62.5%
10/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin GVHD
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin tear (coccyx)
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
itchy skin at PICC site
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
petechial rash on BLE's
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
petechial rash on BLEs
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Hematoma
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Hypotension
|
28.6%
2/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
31.2%
5/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Endocrine disorders
Blood Lactate Dehydrogenase increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
43.8%
7/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
66.7%
2/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
40.0%
6/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
8/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Bleeding from gums
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Blood bicarbonate decreased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
heart murmur
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Glucosuria
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Hyperphosphatemia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Port Site Bleeding
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Scraped LLL bleed
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
TSH increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Blood and lymphatic system disorders
Transaminase elevation
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Heart failure
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
40.0%
6/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Tachypnea
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Ear and labyrinth disorders
mastoid cell effusion
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
Subjunctival Hemorrhage
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
anisocoria
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
double vision
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
left conjunctiva hemorrhage
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
left upper eyelid stye
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
stye - left upper eyelid
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Eye disorders
subconjunctival hemorrhage
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Colitis
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
50.0%
2/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
53.3%
8/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
43.8%
7/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
100.0%
3/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Esophageal pain
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Esophagitis
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
46.7%
7/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
4/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Oral pain
|
28.6%
2/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Thrush
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
5/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
18.8%
3/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
pancreatic head hypodensity
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
taste changes
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
AST Increased
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Chills
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
25.0%
1/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Diaphoresis
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Edema limbs
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
56.2%
9/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Edema trunk
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Fatigue
|
28.6%
2/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
75.0%
3/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
53.3%
8/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
43.8%
7/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Fever
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
37.5%
6/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Flu like symptoms
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Infusion related reaction
|
14.3%
1/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Intermittent bleeding from BMBx site
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Joint pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.7%
1/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Localized edema
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
33.3%
1/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
20.0%
3/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Lower Back Pain
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Malaise
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
13.3%
2/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
12.5%
2/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
|
General disorders
Muscle cramp
|
0.00%
0/7 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/4 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/3 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
0.00%
0/15 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
6.2%
1/16 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, from the date of registration through the date of off study, for a total of 1 lead-in and 12 combination cycles (corresponding to 52 weeks).
AEs were collected by grade (using CTCAE 5.0) and treatment attribution, and max grade by toxicity type was calculated. All enrolled participants monitored/assessed for All-Cause Mortality. All participants who received at least 1 dose of ipilimumab monitored/assessed for Serious and Other (Not Including Serious) Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60