Trial Outcomes & Findings for Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer (NCT NCT02314169)
NCT ID: NCT02314169
Last Updated: 2026-05-12
Results Overview
Responses assessed using computed tomography (CT) scans or magnetic resonance imaging according to standard Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria in order to assess disease progression. Complete Response (CR): Disappearance all target lesions; any pathological lymph nodes reduction in short axis to \< 10 mm (\< 1 cm). Partial Response (PR): \> 30% decrease in sum diameters of target lesions. Progressive Disease (PD): \> 20% increase in sum diameters lesions. (Note: appearance of one or \> new lesions considered progressions). Stable Disease (SD): Neither shrinkage qualify for PR nor increase for PD.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2026-05-12
Participant Flow
Participant milestones
| Measure |
Part A (Nivolumab)
Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Part B Arm I (Nivolumab)
Patients receive nivolumab IV over 30 minutes once every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Part B Arm II (Nivolumab, Ipilimumab)
Patients receive nivolumab as in Arm I. Patients also receive ipilimumab IV over 30 minutes once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
53
|
51
|
|
Overall Study
COMPLETED
|
37
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
4
|
Reasons for withdrawal
| Measure |
Part A (Nivolumab)
Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Part B Arm I (Nivolumab)
Patients receive nivolumab IV over 30 minutes once every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Part B Arm II (Nivolumab, Ipilimumab)
Patients receive nivolumab as in Arm I. Patients also receive ipilimumab IV over 30 minutes once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
3
|
|
Overall Study
Did not meet an eligibility criterion and not treated
|
2
|
0
|
0
|
Baseline Characteristics
Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
Baseline characteristics by cohort
| Measure |
Part A (Nivolumab)
n=39 Participants
Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Part B1 (Nivolumab)
n=53 Participants
Patients receive nivolumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Part B2 (Nivolumab + Ipilimumab)
n=51 Participants
Patients receive nivolumab +/- ipilimumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=1512 Participants
|
59 years
n=504 Participants
|
60 years
n=2016 Participants
|
59 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=1512 Participants
|
42 Participants
n=504 Participants
|
39 Participants
n=2016 Participants
|
109 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=1512 Participants
|
11 Participants
n=504 Participants
|
12 Participants
n=2016 Participants
|
34 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=1512 Participants
|
53 Participants
n=504 Participants
|
47 Participants
n=2016 Participants
|
137 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=1512 Participants
|
50 Participants
n=504 Participants
|
47 Participants
n=2016 Participants
|
131 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=1512 Participants
|
53 participants
n=504 Participants
|
51 participants
n=2016 Participants
|
143 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsResponses assessed using computed tomography (CT) scans or magnetic resonance imaging according to standard Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria in order to assess disease progression. Complete Response (CR): Disappearance all target lesions; any pathological lymph nodes reduction in short axis to \< 10 mm (\< 1 cm). Partial Response (PR): \> 30% decrease in sum diameters of target lesions. Progressive Disease (PD): \> 20% increase in sum diameters lesions. (Note: appearance of one or \> new lesions considered progressions). Stable Disease (SD): Neither shrinkage qualify for PR nor increase for PD.
Outcome measures
| Measure |
Part A: Nivolumab
n=37 Participants
This primary outcome measure is assessed from patients enrolled onto Part A of this study.
|
Part B Arm II (Nivolumab, Ipilimumab
Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
|
|---|---|---|
|
Overall Response Rate: Number of Participants With Response (Part A)
|
24 percentage of patients with a response
Interval 15.0 to 33.0
|
—
|
PRIMARY outcome
Timeframe: Time period from the date of randomization to the date of PD or death whichever occurred first, assessed up to 2 yearsFrom initiation of treatment with nivolumab until the time of disease progression, time measured in months. Kaplan-Meier analysis performed to estimate the median progression-free survival with a 90% confidence interval.
Outcome measures
| Measure |
Part A: Nivolumab
n=52 Participants
This primary outcome measure is assessed from patients enrolled onto Part A of this study.
|
Part B Arm II (Nivolumab, Ipilimumab
n=48 Participants
Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
|
|---|---|---|
|
Progression-free Survival (PFS) (Part B)
|
2.9 months
Interval 1.9 to 3.8
|
3.7 months
Interval 2.0 to 5.6
|
SECONDARY outcome
Timeframe: Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatmentPopulation: This analysis includes only those patients who received at least one dose of study drug.
Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The highest grade that occurred for a participant was recorded per toxicity.
Outcome measures
| Measure |
Part A: Nivolumab
n=37 Participants
This primary outcome measure is assessed from patients enrolled onto Part A of this study.
|
Part B Arm II (Nivolumab, Ipilimumab
Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
|
|---|---|---|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Constipation · Did not experience this adverse event
|
27 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Anorexia · Grade 1
|
5 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Anorexia · Grade 2
|
4 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Anorexia · Grade 3
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Anorexia · Did not experience this adverse event
|
28 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Diarrhea · Grade 1
|
8 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Diarrhea · Grade 2
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Diarrhea · Grade 3
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Diarrhea · Did not experience this adverse event
|
29 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Weight loss · Grade 1
|
5 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Weight loss · Grade 2
|
1 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Weight loss · Grade 3
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Nausea · Grade 2
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Nausea · Grade 3
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Nausea · Did not experience this adverse event
|
35 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Pneumonitis · Grade 1
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Pneumonitis · Grade 2
|
1 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Pneumonitis · Grade 3
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Pneumonitis · Did not experience this adverse event
|
36 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Weight loss · Did not experience this adverse event
|
31 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Arthralgia · Grade 1
|
3 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Arthralgia · Grade 2
|
3 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Arthralgia · Grade 3
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Arthralgia · Did not experience this adverse event
|
31 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Hyperglycaemia · Grade 1
|
3 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Hyperglycaemia · Grade 2
|
1 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Hyperglycaemia · Grade 3
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Hyperglycaemia · Did not experience this adverse event
|
33 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Hypothyroidism · Grade 1
|
1 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Hypothyroidism · Grade 2
|
1 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Hypothyroidism · Grade 3
|
1 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Hypothyroidism · Did not experience this adverse event
|
34 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Lymphoedema · Grade 1
|
1 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Lymphoedema · Grade 2
|
1 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Lymphoedema · Grade 3
|
0 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Lymphoedema · Did not experience this adverse event
|
35 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Nausea · Grade 1
|
2 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Anaemia · Grade 1
|
13 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Anaemia · Grade 2
|
11 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Anaemia · Grade 3
|
2 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Anaemia · Did not experience this adverse event
|
11 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Fatigue · Grade 1
|
17 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Fatigue · Grade 2
|
7 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Fatigue · Grade 3
|
1 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Fatigue · Did not experience this adverse event
|
12 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Rash · Grade 1
|
8 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Rash · Grade 2
|
2 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Rash · Grade 3
|
1 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Rash · Did not experience this adverse event
|
26 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Constipation · Grade 1
|
8 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Constipation · Grade 2
|
2 Participants
|
—
|
|
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
Constipation · Grade 3
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From initiation of treatment until death, assessed up to 2 yearsTime measured from initiation of treatment till death. Kaplan-Meier analysis will be performed to estimate the median overall survival with a 95% confidence interval.
Outcome measures
| Measure |
Part A: Nivolumab
n=37 Participants
This primary outcome measure is assessed from patients enrolled onto Part A of this study.
|
Part B Arm II (Nivolumab, Ipilimumab
Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
|
|---|---|---|
|
Overall Survival (Part A)
|
11.5 months
Interval 7.1 to
The upper limit of the 95% confidence interval was not reached at the time of data analysis.
|
—
|
SECONDARY outcome
Timeframe: From initiation of treatment until death, assessed up to 2 yearsTime measured from initiation of treatment till death. Kaplan-Meier analysis will be performed to estimate the median overall survival with a 90% confidence interval.
Outcome measures
| Measure |
Part A: Nivolumab
n=52 Participants
This primary outcome measure is assessed from patients enrolled onto Part A of this study.
|
Part B Arm II (Nivolumab, Ipilimumab
n=48 Participants
Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
|
|---|---|---|
|
Overall Survival (Part B)
|
15.9 months
Interval 11.3 to 33.4
|
20 months
Interval 15.4 to 23.0
|
SECONDARY outcome
Timeframe: From initiation of treatment with nivolumab until the time of disease progression, assessed up to 2 yearsFrom initiation of treatment with nivolumab until the time of disease progression, time measured in months. Kaplan-Meier analysis performed to estimate the median progression-free survival with a 95% confidence interval.
Outcome measures
| Measure |
Part A: Nivolumab
n=37 Participants
This primary outcome measure is assessed from patients enrolled onto Part A of this study.
|
Part B Arm II (Nivolumab, Ipilimumab
Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
|
|---|---|---|
|
Progression-free Survival (Part A)
|
4.1 months
Interval 3.0 to 7.9
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Of the 100 participants enrolled into Part B of the study, 88 participants were evaluable for response per RECIST 1.1. The remaining 12 participants were not evaluable for treatment response.
Responses assessed using CT scans or magnetic resonance imaging according to standard RECIST 1.1 criteria in order to assess disease progression. CR: Disappearance all target lesions; any pathological lymph nodes reduction in short axis to \< 10 mm (\< 1 cm). PR: \> 30% decrease in sum diameters of target lesions. PD: \> 20% increase in sum diameters lesions. (Note: appearance of one or \> new lesions considered progressions). SD: Neither shrinkage qualify for PR nor increase for PD.
Outcome measures
| Measure |
Part A: Nivolumab
n=46 Participants
This primary outcome measure is assessed from patients enrolled onto Part A of this study.
|
Part B Arm II (Nivolumab, Ipilimumab
n=42 Participants
Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
|
|---|---|---|
|
Overall Response Rate (Part B)
|
17.4 percentage of participants
Interval 9.1 to 31.0
|
21.5 percentage of participants
Interval 12.0 to 36.0
|
SECONDARY outcome
Timeframe: Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatmentToxicities were assessed by CTCAE version 5.0. The highest grade that occurred for a participant was recorded per toxicity.
Outcome measures
| Measure |
Part A: Nivolumab
n=52 Participants
This primary outcome measure is assessed from patients enrolled onto Part A of this study.
|
Part B Arm II (Nivolumab, Ipilimumab
n=48 Participants
Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
|
|---|---|---|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Adrenal insufficiency · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated Alanine Aminotransferase · Grade 3
|
0 Participants
|
2 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated Alanine Aminotransferase · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated Alanine Aminotransferase · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated Alanine Aminotransferase · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
46 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Anemia · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Anemia · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Anemia · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Anemia · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated Aspartate Aminotransferase · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated Aspartate Aminotransferase · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated Aspartate Aminotransferase · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated Aspartate Aminotransferase · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated blood bilirubin · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated blood bilirubin · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated blood bilirubin · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Elevated blood bilirubin · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
COVID-19 infection · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
COVID-19 infection · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
COVID-19 infection · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
COVID-19 infection · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Fatigue · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Fatigue · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Fatigue · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Fatigue · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hyperglycemia · Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hyperglycemia · Grade 4
|
0 Participants
|
3 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hyperglycemia · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hyperglycemia · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
45 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypokalemia · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypokalemia · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypokalemia · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypokalemia · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hyponatremia · Grade 3
|
2 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hyponatremia · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hyponatremia · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hyponatremia · Did not experience a Grade 3, 4, or 5 event
|
50 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypophosphatemia · Grade 3
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypophosphatemia · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypophosphatemia · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypophosphatemia · Did not experience a Grade 3, 4, or 5 event
|
51 Participants
|
48 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypophysitis · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypophysitis · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypophysitis · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Hypophysitis · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Lymphocyte count decreased · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Lymphocyte count decreased · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Lymphocyte count decreased · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Lymphocyte count decreased · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Malaise · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Malaise · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Malaise · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Malaise · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Minimal change disease nephrotic syndrome · Grade 3
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Minimal change disease nephrotic syndrome · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Minimal change disease nephrotic syndrome · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Minimal change disease nephrotic syndrome · Did not experience a Grade 3, 4, or 5 event
|
51 Participants
|
48 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Pneumonitis · Grade 3
|
0 Participants
|
3 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Pneumonitis · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Pneumonitis · Grade 5
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Pneumonitis · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
44 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Rash macula-papular · Grade 3
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Rash macula-papular · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Rash macula-papular · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Rash macula-papular · Did not experience a Grade 3, 4, or 5 event
|
51 Participants
|
48 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Vomiting · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Vomiting · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Vomiting · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Vomiting · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Lung Infection · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Lung Infection · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Lung Infection · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Lung Infection · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Adrenal insufficiency · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Abdominal distension · Grade 3
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Abdominal distension · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Abdominal distension · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Abdominal distension · Did not experience a Grade 3, 4, or 5 event
|
51 Participants
|
48 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Abdominal pain · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Abdominal pain · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Abdominal pain · Grade 5
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Abdominal pain · Did not experience a Grade 3, 4, or 5 event
|
52 Participants
|
47 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Adrenal insufficiency · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Adrenal insufficiency · Grade 4
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to time of treatment discontinuationDescriptive statistics including plots, mean, median and standard deviations will be used to summarize data. For continuous outcomes, t-test and analysis of variance will be used to compare outcome measures across patient characteristics. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square test or Fisher's exact test will be used to test the association between two categorical variables. Both univariate and multivariate logistic regressions will be performed to model prognostic factors.
Outcome measures
Outcome data not reported
Adverse Events
Part A (Nivolumab)
Serious events: 14 serious events
Other events: 36 other events
Deaths: 16 deaths
Part B1 (Nivolumab)
Serious events: 25 serious events
Other events: 48 other events
Deaths: 28 deaths
Part B2 (Nivolumab + Ipilimumab)
Serious events: 19 serious events
Other events: 46 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Part A (Nivolumab)
n=37 participants at risk
Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Part B1 (Nivolumab)
n=52 participants at risk
Patients receive nivolumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Part B2 (Nivolumab + Ipilimumab)
n=48 participants at risk
Patients receive nivolumab +/- ipilimumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|---|---|
|
General disorders
Pain
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
2/37 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
3.8%
2/52 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
5.4%
2/37 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Nervous system disorders
Aphasia
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Cardiac disorders
Cardiac troponin I increased
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Psychiatric disorders
Confusion
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Infections and infestations
COVID-19
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Investigations
Creatinine increased
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Psychiatric disorders
Delirium
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Disease progression
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Edema limbs
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Injury, poisoning and procedural complications
Fall
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Fever
|
10.8%
4/37 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Fatigue
|
5.4%
2/37 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Vascular disorders
Hypertension
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Renal and urinary disorders
Kidney infection
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Large bowel obstruction
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Investigations
Lymphocyte count decreased
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
malaise
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Renal and urinary disorders
Miniimal change disease nephrotic syndrome
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Infections and infestations
MRSA
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Cardiac disorders
Non-cardiac chest pain
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Hepatobiliary disorders
Obstructive hyperbilirubinemia
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
8.3%
4/48 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Progression of Disease
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Nervous system disorders
Seizure
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Infections and infestations
Sepsis
|
5.4%
2/37 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Infections and infestations
Soft tissue infection
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Sudden death NOS
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Symptomatic Brain Metastases
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Infections and infestations
Systemic Inflammatory Response Syndrome
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Vascular disorders
Thromboembolic event
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Renal and urinary disorders
Urinary retention
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
5.4%
2/37 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
5.8%
3/52 • Number of events 5 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
Other adverse events
| Measure |
Part A (Nivolumab)
n=37 participants at risk
Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Part B1 (Nivolumab)
n=52 participants at risk
Patients receive nivolumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
Part B2 (Nivolumab + Ipilimumab)
n=48 participants at risk
Patients receive nivolumab +/- ipilimumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|---|---|
|
Investigations
Alkaline phosphatase increased
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
17.3%
9/52 • Number of events 16 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
10.4%
5/48 • Number of events 11 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Blood and lymphatic system disorders
Anemia
|
43.2%
16/37 • Number of events 69 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
28.8%
15/52 • Number of events 85 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
33.3%
16/48 • Number of events 36 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
21.6%
8/37 • Number of events 41 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
21.2%
11/52 • Number of events 29 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
22.9%
11/48 • Number of events 20 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
10.8%
4/37 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
21.2%
11/52 • Number of events 17 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
20.8%
10/48 • Number of events 20 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
3.8%
2/52 • Number of events 5 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
10.4%
5/48 • Number of events 11 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
7.7%
4/52 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 7 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
5/37 • Number of events 25 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
7.7%
4/52 • Number of events 65 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
10.4%
5/48 • Number of events 8 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
5.8%
3/52 • Number of events 9 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
18.9%
7/37 • Number of events 33 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
7.7%
4/52 • Number of events 16 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
12.5%
6/48 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.2%
6/37 • Number of events 70 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
5.8%
3/52 • Number of events 39 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
10.4%
5/48 • Number of events 5 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Chills
|
5.4%
2/37 • Number of events 68 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
13.5%
7/52 • Number of events 16 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
14.6%
7/48 • Number of events 9 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Constipation
|
29.7%
11/37 • Number of events 61 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
17.3%
9/52 • Number of events 51 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
12.5%
6/48 • Number of events 12 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.2%
6/37 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
9.6%
5/52 • Number of events 8 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
8.3%
4/48 • Number of events 8 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Investigations
Creatinine increased
|
32.4%
12/37 • Number of events 68 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
13.5%
7/52 • Number of events 38 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Diarrhea
|
29.7%
11/37 • Number of events 46 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
23.1%
12/52 • Number of events 46 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
25.0%
12/48 • Number of events 25 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dizziness
|
8.1%
3/37 • Number of events 13 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
7.7%
4/52 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
10.4%
5/48 • Number of events 5 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Dry mouth
|
5.4%
2/37 • Number of events 60 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
3.8%
2/52 • Number of events 5 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
10.4%
5/48 • Number of events 14 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.1%
3/37 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
12.5%
6/48 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.1%
3/37 • Number of events 6 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
9.6%
5/52 • Number of events 25 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
16.7%
8/48 • Number of events 12 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Edema limbs
|
8.1%
3/37 • Number of events 20 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
11.5%
6/52 • Number of events 14 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Fatigue
|
54.1%
20/37 • Number of events 209 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
40.4%
21/52 • Number of events 93 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
41.7%
20/48 • Number of events 60 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Fever
|
24.3%
9/37 • Number of events 14 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
11.5%
6/52 • Number of events 8 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
12.5%
6/48 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
11.5%
6/52 • Number of events 24 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Nervous system disorders
Headache
|
8.1%
3/37 • Number of events 6 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
9.6%
5/52 • Number of events 9 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
4.2%
2/48 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Renal and urinary disorders
Hematuria
|
8.1%
3/37 • Number of events 23 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
5.8%
3/52 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
4.2%
2/48 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.2%
6/37 • Number of events 19 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
11.5%
6/52 • Number of events 25 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
14.6%
7/48 • Number of events 15 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.2%
6/37 • Number of events 18 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
3.8%
2/52 • Number of events 6 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Vascular disorders
Hypertension
|
10.8%
4/37 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
3.8%
2/52 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.9%
7/37 • Number of events 33 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
11.5%
6/52 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
12.5%
6/48 • Number of events 9 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.4%
2/37 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
7.7%
4/52 • Number of events 6 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 5 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
2/37 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
9.6%
5/52 • Number of events 7 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
8.3%
4/48 • Number of events 9 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.9%
7/37 • Number of events 22 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
5.8%
3/52 • Number of events 6 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/48 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.2%
6/37 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
17.3%
9/52 • Number of events 20 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
14.6%
7/48 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Endocrine disorders
Hypothyroidism
|
2.7%
1/37 • Number of events 13 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
7.7%
4/52 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
14.6%
7/48 • Number of events 37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Psychiatric disorders
Insomnia
|
13.5%
5/37 • Number of events 13 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
5.8%
3/52 • Number of events 32 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
4.2%
2/48 • Number of events 13 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Investigations
Lymphocyte count decreased
|
2.7%
1/37 • Number of events 6 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
15.4%
8/52 • Number of events 36 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
4.2%
2/48 • Number of events 8 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
3.8%
2/52 • Number of events 7 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
12.5%
6/48 • Number of events 13 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.8%
4/37 • Number of events 21 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 5 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
32.4%
12/37 • Number of events 71 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
23.1%
12/52 • Number of events 21 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
27.1%
13/48 • Number of events 33 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Non-cardiac chest pain
|
8.1%
3/37 • Number of events 8 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
8.3%
4/48 • Number of events 5 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
General disorders
Pain
|
24.3%
9/37 • Number of events 62 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
9.6%
5/52 • Number of events 32 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
12.5%
6/48 • Number of events 7 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.2%
6/37 • Number of events 9 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
5.8%
3/52 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 8 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.4%
2/37 • Number of events 26 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
5.8%
3/52 • Number of events 61 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
8.3%
4/48 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Investigations
Platelet count decreased
|
8.1%
3/37 • Number of events 35 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
7.7%
4/52 • Number of events 7 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
8.3%
4/48 • Number of events 6 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
2/37 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
13.5%
7/52 • Number of events 27 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
12.5%
6/48 • Number of events 20 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
21.6%
8/37 • Number of events 29 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
0.00%
0/52 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.8%
4/37 • Number of events 13 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
15.4%
8/52 • Number of events 14 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
16.7%
8/48 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Rectal pain
|
5.4%
2/37 • Number of events 13 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
5.8%
3/52 • Number of events 6 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
4.2%
2/48 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Cardiac disorders
Sinus tachycardia
|
5.4%
2/37 • Number of events 3 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
3.8%
2/52 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 2 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
18.9%
7/37 • Number of events 13 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
11.5%
6/52 • Number of events 11 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
29.7%
11/37 • Number of events 15 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
11.5%
6/52 • Number of events 6 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
14.6%
7/48 • Number of events 10 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Investigations
Weight loss
|
13.5%
5/37 • Number of events 32 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
7.7%
4/52 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
6.2%
3/48 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
|
Investigations
White blood cell decreased
|
0.00%
0/37 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
5.8%
3/52 • Number of events 4 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
8.3%
4/48 • Number of events 6 • Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60