Trial Outcomes & Findings for Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting (NCT NCT03743766)
NCT ID: NCT03743766
Last Updated: 2026-08-31
Results Overview
Percent Lymphocyte-activation gene 3 (LAG3) level (cell surface molecule expressed on activated T cells) expression from scRNAseq
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
At Baseline
Results posted on
2026-08-31
Participant Flow
Participant milestones
| Measure |
Relatlimab
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
14
|
|
Overall Study
COMPLETED
|
14
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting
Baseline characteristics by cohort
| Measure |
Relatlimab
n=14 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=15 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=14 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.00 years
n=14 Participants
|
69.00 years
n=36 Participants
|
60.00 years
n=324 Participants
|
67.00 years
n=49 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
7 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
15 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
8 Participants
n=36 Participants
|
10 Participants
n=324 Participants
|
28 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=14 Participants
|
15 Participants
n=36 Participants
|
14 Participants
n=324 Participants
|
43 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=14 Participants
|
15 Participants
n=36 Participants
|
14 Participants
n=324 Participants
|
43 Participants
n=49 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
BRAF.STATUS
Wild-Type
|
4 Participants
n=14 Participants
|
9 Participants
n=36 Participants
|
7 Participants
n=324 Participants
|
20 Participants
n=49 Participants
|
|
BRAF.STATUS
Mutated
|
7 Participants
n=14 Participants
|
5 Participants
n=36 Participants
|
6 Participants
n=324 Participants
|
18 Participants
n=49 Participants
|
|
BRAF.STATUS
Unknown
|
3 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
5 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided tumor biopsy and peripheral blood performed prior to the first dose of study drug.
Percent Lymphocyte-activation gene 3 (LAG3) level (cell surface molecule expressed on activated T cells) expression from scRNAseq
Outcome measures
| Measure |
Relatlimab
n=6 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=8 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=9 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
LAG3 Gene Expression From scRNAseq
|
0.78 percent
Standard Deviation 1.27
|
2.94 percent
Standard Deviation 4.28
|
9.37 percent
Standard Deviation 10.93
|
PRIMARY outcome
Timeframe: At Week 4Population: Treated patients who provided tumor biopsy and peripheral blood performed following 1 cycle (4 weeks) of the assigned treatment for lead-in phase.
Percent Lymphocyte-activation gene 3 (LAG3) level (cell surface molecule expressed on activated T cells) expression from scRNAseq
Outcome measures
| Measure |
Relatlimab
n=6 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=8 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=9 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
LAG3 Gene Expression From scRNAseq
|
0.96 percent
Standard Deviation 2.01
|
13.12 percent
Standard Deviation 22.02
|
13.50 percent
Standard Deviation 9.31
|
PRIMARY outcome
Timeframe: At baseline (Week 0)Population: Treated patients who provided tumor biopsy and peripheral blood performed following 1 cycle (4 weeks) of the assigned treatment for lead-in phase.
Percent PD1 (programmed cell death protein 1) expression after completion of lead-in phase.
Outcome measures
| Measure |
Relatlimab
n=6 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=8 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=9 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
PD1 Expression
|
9.29 percent
Standard Deviation 14.77
|
5.43 percent
Standard Deviation 5.09
|
12.28 percent
Standard Deviation 9.47
|
PRIMARY outcome
Timeframe: At Week 4Population: Treated patients who provided tumor biopsy and peripheral blood performed following 1 cycle (4 weeks) of the assigned treatment for lead-in phase.
Percent PD1 (programmed cell death protein 1) expression after completion of lead-in phase.
Outcome measures
| Measure |
Relatlimab
n=6 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=8 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=9 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
PD1 Expression
|
2.91 percent
Standard Deviation 3.11
|
5.78 percent
Standard Deviation 4.78
|
6.19 percent
Standard Deviation 5.09
|
PRIMARY outcome
Timeframe: At baseline and at 4 weeksPopulation: Treated patients who were evaluable for radiologic response.
Percentage change in tumor size assessed per Response Evaluation Criteria in Solid Tumors. Per RECIST 1.1, Tumor lesions: Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of: * 10 mm by CT scan (CT scan slice thickness no greater than 5 mm; see Appendix II on imaging guidance). * 10 mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as non-measurable). * 20 mm by chest X-ray.
Outcome measures
| Measure |
Relatlimab
n=6 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=8 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=9 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Change in Tumor Size
|
10 percent change
Interval -2.0 to 28.0
|
3 percent change
Interval -8.0 to 18.0
|
-5 percent change
Interval -6.0 to 1.0
|
PRIMARY outcome
Timeframe: Beginning at 12 weeks post initial treatment, up to 4 yearsPopulation: Treated patients evaluable for radiologic response.
Percent of participants experiencing Complete Response (CR) + Number of participants experiencing Partial Response (PR)/total patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Overall Response Rate (ORR)
|
20 percentage of patients
Interval 3.68 to 50.69
|
50 percentage of patients
Interval 26.36 to 73.64
|
46.15 percentage of patients
Interval 22.4 to 71.3
|
PRIMARY outcome
Timeframe: Beginning at 12 weeks post initial treatment, up to 4 yearsPopulation: All treated patients including those who have missing clinical response assessments at week 4 or week 16 are counted as non-responders.
Percent of participants experiencing Complete Response (CR) + Number of participants experiencing Partial Response (PR)/total patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Relatlimab
n=14 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=15 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=14 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Overall Response Rate (ORR) - ITT (Intent-to-treat) Population
|
14.29 percentage of patients
Interval 2.6 to 38.54
|
46.67 percentage of patients
Interval 24.37 to 70.0
|
42.86 percentage of patients
Interval 20.61 to 67.5
|
SECONDARY outcome
Timeframe: 12 weeks post initial treatment, up to 4 yearsPopulation: Evaluable population (n=37): Excluding the 6 patients who have missing clinical response assessments at week 4 or week 16.
Percent of patients with Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) / total patients assessed per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Secondary Outcome: Clinical Benefit Rate
|
80 Percentage
Interval 49.31 to 96.32
|
78.57 Percentage
Interval 53.43 to 93.89
|
76.92 Percentage
Interval 50.54 to 93.4
|
SECONDARY outcome
Timeframe: 12 weeks post initial treatment, up to 4 yearsPopulation: In the ITT analysis, the 6 patients who have missing clinical response assessments at week 4 or week 16 are counted as non-responders. Treating patients with missing week 4 or week 16 clinical response assessments as having no clinical benefit yields a clinical benefit rate.
Percent of patients with Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) / total patients assessed per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Relatlimab
n=14 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=15 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=14 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Clinical Benefit Rate - ITT (Intent-to-treat) Population
|
57.14 Percentage
Interval 32.5 to 79.39
|
73.33 Percentage
Interval 48.92 to 90.33
|
71.43 Percentage
Interval 46.0 to 89.6
|
SECONDARY outcome
Timeframe: 12 weeks post initial treatment, up to 4 yearsPopulation: Treated patients who were radiologically evaluable.
Time from first documented Complete Response (CR) or Partial Response (PR) until the first date that progressive disease is objectively documented. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Relatlimab
n=3 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=9 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=9 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Duration of Response
|
NA months
Interval 22.4 to
Median and Upper bound of 95% CI not reached due to insufficient events.
|
NA months
Interval 37.5 to
Median and Upper bound of 95% CI not reached due to insufficient events.
|
NA months
Median and 95% CI not reached due to insufficient events.
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Treated patients who were radiologically evaluable.
Progression-free survival is defined as the time between the date of randomization and the first date of documented progression or death due to any cause, whichever occurs first. Per RECIST v1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Relatlimab
n=14 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=15 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=14 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
1.9 months
Interval 0.9 to
Upper bound of 95% CI not reached due to insufficient events.
|
4.7 months
Interval 1.0 to
Upper bound of 95% CI not reached due to insufficient events.
|
14.7 months
Interval 9.1 to
Upper bound of 95% CI not reached due to insufficient events.
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Treated patients who were radiologically evaluable.
Progression-free survival is defined as the time between the date of randomization and the first date of documented progression or death due to any cause, whichever occurs first. Per RECIST v1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Relatlimab
n=14 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=15 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=14 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Progression-free Survival (PFS) by Lead-in Arm
|
1.9 months
Interval 0.9 to
Upper bound of 95% CI not reached due to insufficient events.
|
4.7 months
Interval 1.0 to
Upper bound of 95% CI not reached due to insufficient events.
|
14.7 months
Interval 9.1 to
Upper bound of 95% CI not reached due to insufficient events.
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: All randomized patients.
Overall survival is defined as the time between the date of randomization and the date of death due to any cause.
Outcome measures
| Measure |
Relatlimab
n=14 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=15 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=14 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Overall Survival (OS)
|
23.6 months
Interval 12.1 to
Upper bound of 95% CI not reached due to insufficient events.
|
41.1 months
Interval 19.0 to
Upper bound of 95% CI not reached due to insufficient events.
|
NA months
Interval 27.7 to
Median and Upper bound of 95% CI not reached due to insufficient events.
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
Number of CD8+ tumor infiltrating lymphocytes present.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
CD8+ Tumor Infiltrating Lymphocytes
|
0.410590278 proportion of immune cells
Interval 0.143863179 to 0.513750731
|
0.359393872 proportion of immune cells
Interval 0.2011635366359 to 0.549686402
|
0.36241623 proportion of immune cells
Interval 0.200645966 to 0.4794291948955
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
Number of CD8+ tumor infiltrating lymphocytes present.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
CD8+ Tumor Infiltrating Lymphocytes
|
0.496584699 proportion of immune cells
Interval 0.451612903 to 0.5733944954128
|
0.382900483 proportion of immune cells
Interval 0.271371353 to 0.47105706
|
0.519125683 proportion of immune cells
Interval 0.41891900003 to 0.6266313145408
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
Number of CD4+ tumor infiltrating lymphocytes present.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
CD4+ Tumor Infiltrating Lymphocytes
|
0.23392283 proportion of immune cells
Interval 0.150561798 to 0.281420765
|
0.194253553 proportion of immune cells
Interval 0.058145753 to 0.2949838417982
|
0.220195639 proportion of immune cells
Interval 0.175148548 to 0.257110926
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
Number of CD4+ tumor infiltrating lymphocytes present.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
CD4+ Tumor Infiltrating Lymphocytes
|
0.221945137 proportion of immune cells
Interval 0.136363636 to 0.32193159
|
0.236556234 proportion of immune cells
Interval 0.2097374566643 to 0.277051228
|
0.24424409 proportion of immune cells
Interval 0.213976252 to 0.392482686
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
To determine the amount of LAG3 expressed on activated T cells in the blood through single-cell RNA sequencing. The LAG3 expression is reported as the natural log (ln) of the number of LAG3 transcripts divided by the number of total mapped reads plus 1.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
LAG3 Levels - PBMC
|
117.4181801 ln(LAG3 transcripts/totalmappedreads+1)
Interval 61.54439729 to 294.4849249
|
87.41155574 ln(LAG3 transcripts/totalmappedreads+1)
Interval 47.96758893 to 142.8924017
|
81.63475936 ln(LAG3 transcripts/totalmappedreads+1)
Interval 70.23308523 to 142.5931631
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
To determine the amount of LAG3 expressed on activated T cells in the blood through single-cell RNA sequencing. The LAG3 expression is reported as the natural log (ln) of the number of LAG3 transcripts divided by the number of total mapped reads plus 1.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
LAG3 Levels - PBMC
|
24.413734087489 ln(LAG3 transcripts/totalmappedreads+1)
Interval 9.3474180371759 to 62.236318580783
|
85.234642328843 ln(LAG3 transcripts/totalmappedreads+1)
Interval 18.302744806527 to 153.60255356972
|
114.21499509798 ln(LAG3 transcripts/totalmappedreads+1)
Interval 38.868567296591 to 207.59732584449
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
To determine the amount of LAG3 expressed on activated tumor infiltrating lymphocytes (TIL) through single-cell RNA sequencing. The LAG3 expression is reported as the natural log (ln) of the number of LAG3 transcripts divided by the number of total mapped reads plus 1.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
LAG3 Levels - TIL
|
553.0461253 ln(LAG3 transcripts/totalmappedreads+1)
Interval 41.26380993 to 1527.474199
|
781.0925834 ln(LAG3 transcripts/totalmappedreads+1)
Interval 227.8971686 to 2620.194512
|
294.6551121 ln(LAG3 transcripts/totalmappedreads+1)
Interval 48.9453378 to 671.3791451
|
SECONDARY outcome
Timeframe: At Week 16Population: Treated patients who provided samples for analysis.
To determine the amount of LAG3 expressed on activated T cells in the blood through single-cell RNA sequencing. The LAG3 expression is reported as the natural log (ln) of the number of LAG3 transcripts divided by the number of total mapped reads plus 1.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
LAG3 Levels - PBMC
|
78.30750135 ln(LAG3 transcripts/totalmappedreads+1)
Interval 39.7607976 to 105.623955
|
208.2743213 ln(LAG3 transcripts/totalmappedreads+1)
Interval 92.76860627 to 403.4555187
|
115.7683188 ln(LAG3 transcripts/totalmappedreads+1)
Interval 82.53645799 to 186.7920792
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
To determine the amount of LAG3 expressed on activated tumor infiltrating lymphocytes (TIL) through single-cell RNA sequencing. The LAG3 expression is reported as the natural log (ln) of the number of LAG3 transcripts divided by the number of total mapped reads plus 1.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
LAG3 Levels - TIL
|
484.95998714484 ln(LAG3 transcripts/totalmappedreads+1)
Interval 349.03637689208 to 673.13564639344
|
181.73348534061 ln(LAG3 transcripts/totalmappedreads+1)
Interval 108.66150695992 to 280.97789375502
|
191.56231622054 ln(LAG3 transcripts/totalmappedreads+1)
Interval 101.93016786268 to 1468.6099534725
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
To determine the amount of PD-1 (programmed cell death protein 1) expressed on PBMCs through single-cell RNA sequencing in treated patients. The PD-1 expression is reported as the natural log (ln) of the number of PD-1 transcripts divided by the number of total mapped reads plus 1.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
PD-1 Expression in PBMC
|
35.71568809 ln(PD-1 transcripts/totalmappedreads+1)
Interval 16.03550284 to 57.00538064
|
21.75600549 ln(PD-1 transcripts/totalmappedreads+1)
Interval 15.15743416 to 35.4023936
|
25.26034324 ln(PD-1 transcripts/totalmappedreads+1)
Interval 18.6050362 to 42.22906242
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
To determine the amount of PD-1 (programmed cell death protein 1) expressed on PBMCs through single-cell RNA sequencing in treated patients. The PD-1 expression is reported as the natural log (ln) of the number of PD-1 transcripts divided by the number of total mapped reads plus 1.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
PD-1 Expression in PBMC
|
4.395254969 ln(PD-1 transcripts/totalmappedreads+1)
Interval 1.524867838 to 27.44315979
|
32.91097578 ln(PD-1 transcripts/totalmappedreads+1)
Interval 15.04585236 to 60.3081099
|
37.82897218 ln(PD-1 transcripts/totalmappedreads+1)
Interval 11.0244881 to 69.37037671
|
SECONDARY outcome
Timeframe: At Week 16Population: Treated patients who provided samples for analysis.
To determine the amount of PD-1 (programmed cell death protein 1) expressed on PBMCs through single-cell RNA sequencing in treated patients. The PD-1 expression is reported as the natural log (ln) of the number of PD-1 transcripts divided by the number of total mapped reads plus 1.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
PD-1 Expression in PBMC
|
28.53794861 ln(PD-1 transcripts/totalmappedreads+1)
Interval 13.86309395 to 51.9408153
|
88.7381496 ln(PD-1 transcripts/totalmappedreads+1)
Interval 39.56943112 to 178.7760098
|
59.92440919 ln(PD-1 transcripts/totalmappedreads+1)
Interval 38.9608126 to 96.098883
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
To determine the amount of PD-1 (programmed cell death protein 1) expressed on TILs through single-cell RNA sequencing in treated patients. The PD-1 expression is reported as the natural log (ln) of the number of PD-1 transcripts divided by the number of total mapped reads plus 1.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
PD-1 Expression in TIL
|
230.9153184 ln(PD-1 transcripts/totalmappedreads+1)
Interval 27.24279784 to 489.0740512
|
449.2734698 ln(PD-1 transcripts/totalmappedreads+1)
Interval 168.6028866 to 885.1304368
|
239.7028054 ln(PD-1 transcripts/totalmappedreads+1)
Interval 28.36920071 to 407.0256233
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
To determine the amount of PD-1 (programmed cell death protein 1) expressed on TILs through single-cell RNA sequencing in treated patients. The PD-1 expression is reported as the natural log (ln) of the number of PD-1 transcripts divided by the number of total mapped reads plus 1.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
PD-1 Expression in TIL
|
228.75905461118 ln(PD-1 transcripts/totalmappedreads+1)
Interval 29.378008590205 to 314.54965409338
|
52.286295752816 ln(PD-1 transcripts/totalmappedreads+1)
Interval 25.095455416135 to 118.50159633512
|
97.373785446401 ln(PD-1 transcripts/totalmappedreads+1)
Interval 54.125072015474 to 723.67240171323
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
Measure of cells that have previously encountered and responded to their cognate antigen in TIL.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Cell Effector/Memory Status - TIL
effector
|
0.005644028 proportion of immune cells
Interval 0.003943448 to 0.069638695
|
0.004836982 proportion of immune cells
Interval 0.003384551 to 0.011538082
|
0.00315595 proportion of immune cells
Interval 0.002346804 to 0.00571541
|
|
Cell Effector/Memory Status - TIL
memory
|
0.032769556 proportion of immune cells
Interval 0.022393822 to 0.055555556
|
0.04014046 proportion of immune cells
Interval 0.026397003 to 0.079803468
|
0.072042923 proportion of immune cells
Interval 0.020349099 to 0.219567669
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
Measure of cells that have previously encountered and responded to their cognate antigen in TIL.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Cell Effector/Memory Status - TIL
memory
|
0.024393456 proportion of immune cells
Interval 0.018188142 to 0.036117078
|
0.050310559 proportion of immune cells
Interval 0.024560063 to 0.069113471
|
0.027002762 proportion of immune cells
Interval 0.017210365 to 0.041072618
|
|
Cell Effector/Memory Status - TIL
effector
|
0.003741315 proportion of immune cells
Interval 0.002638522 to 0.008
|
0.007784912 proportion of immune cells
Interval 0.003288969 to 0.00921277
|
0.006480295 proportion of immune cells
Interval 0.002192184 to 0.015131579
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
Measure of cells that have previously encountered and responded to their cognate antigen in PBMCs.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Cell Effector/Memory Status - PBMCs
memory
|
0.173913043 proportion of immune cells
Interval 0.076345432 to 0.245737212
|
0.137828185 proportion of immune cells
Interval 0.113406637 to 0.181557067
|
0.198312236 proportion of immune cells
Interval 0.121602932 to 0.305413895
|
|
Cell Effector/Memory Status - PBMCs
effector
|
0.029087262 proportion of immune cells
Interval 0.007633588 to 0.078760491
|
0.023693761 proportion of immune cells
Interval 0.018095238 to 0.033324224
|
0.01420765 proportion of immune cells
Interval 0.013335198 to 0.040356548
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
Measure of cells that have previously encountered and responded to their cognate antigen in PBMCs.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Cell Effector/Memory Status - PBMC
memory
|
0.199023648 proportion of immune cells
Interval 0.141758242 to 0.273277512
|
0.162300324 proportion of immune cells
Interval 0.078517448 to 0.243674507
|
0.171945701 proportion of immune cells
Interval 0.089264386 to 0.347987251
|
|
Cell Effector/Memory Status - PBMC
effector
|
0.025974026 proportion of immune cells
Interval 0.019073923 to 0.046315789
|
0.011019284 proportion of immune cells
Interval 0.009361856 to 0.023844932
|
0.029145316 proportion of immune cells
Interval 0.014079027 to 0.038629997
|
SECONDARY outcome
Timeframe: At Week 16Population: Treated patients who provided samples for analysis.
Measure of cells that have previously encountered and responded to their cognate antigen in PBMCs.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Cell Effector/Memory Status - PBMC
memory
|
0.26744186 proportion of immune cells
Interval 0.224274406 to 0.464285714
|
0.181510619 proportion of immune cells
Interval 0.0847756 to 0.375080749
|
0.184960054 proportion of immune cells
Interval 0.11202629 to 0.250726645
|
|
Cell Effector/Memory Status - PBMC
effector
|
0.026155752 proportion of immune cells
Interval 0.018633783 to 0.040069648
|
0.010531062 proportion of immune cells
Interval 0.006688079 to 0.01555367
|
0.010721374 proportion of immune cells
Interval 0.007409468 to 0.020016729
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
Amount of Regulatory T cell (Treg) markers present in PBMCs in treated patients.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Regulatory T Cell (Treg) Marker Levels - PMBCs
|
0.031311275 proportion of immune cells
Interval 0.027668814 to 0.039353362
|
0.032663631 proportion of immune cells
Interval 0.025531943 to 0.038065535
|
0.025919732 proportion of immune cells
Interval 0.013928831 to 0.041448479
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
Amount of Regulatory T cell (Treg) markers present in PBMCs in treated patients.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Regulatory T Cell (Treg) Marker Levels - PMBCs
|
0.027264981 proportion of immune cells
Interval 0.017635861 to 0.051930576
|
0.047009262 proportion of immune cells
Interval 0.036717905 to 0.052503788
|
0.046875 proportion of immune cells
Interval 0.027912065 to 0.053002957
|
SECONDARY outcome
Timeframe: At Week 16Population: Treated patients who provided samples for analysis.
Amount of Regulatory T cell (Treg) markers present in PBMCs in treated patients.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Regulatory T Cell (Treg) Marker Levels - PMBCs
|
0.056900222 proportion of immune cells
Interval 0.028511821 to 0.075614489
|
0.044996348 proportion of immune cells
Interval 0.036690206 to 0.049494691
|
0.038493371 proportion of immune cells
Interval 0.03643035 to 0.045096718
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
Amount of Regulatory T cell (Treg) markers present in TILs in treated patients.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Regulatory T Cell (Treg) Marker Levels - TIL
|
0.05866008 proportion of immune cells
Interval 0.036024306 to 0.093516209
|
0.058558335 proportion of immune cells
Interval 0.047202783 to 0.079397021
|
0.067705317 proportion of immune cells
Interval 0.047454931 to 0.098647656
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
Amount of Regulatory T cell (Treg) markers present in TILs in treated patients.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Regulatory T Cell (Treg) Marker Levels - TIL
|
0.056949153 proportion of immune cells
Interval 0.042696629 to 0.074121289
|
0.026785714 proportion of immune cells
Interval 0.016600266 to 0.063822859
|
0.065735998 proportion of immune cells
Interval 0.049323821 to 0.097586207
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
Measure of expression of activation and maturation of dendritic cells in PBMCs.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Activation and Maturation of Dendritic Cells - PBMC
|
0.03070015 proportion of immune cells
Interval 0.021834008 to 0.041250195
|
0.036025924 proportion of immune cells
Interval 0.021281652 to 0.048815284
|
0.030824639 proportion of immune cells
Interval 0.014091698 to 0.047389263863
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
Measure of expression of activation and maturation of dendritic cells in PBMCs.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Activation and Maturation of Dendritic Cells - PBMC
|
0.03922571 proportion of immune cells
Interval 0.03139739 to 0.058189597
|
0.048762416 proportion of immune cells
Interval 0.039213563 to 0.087995338
|
0.035719581 proportion of immune cells
Interval 0.012278647 to 0.038502674
|
SECONDARY outcome
Timeframe: At Week 16Population: Treated patients who provided samples for analysis.
Measure of expression of activation and maturation of dendritic cells in PBMCs.
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Activation and Maturation of Dendritic Cells - PBMC
|
0.032520325 proportion of immune cells
Interval 0.026083467 to 0.042553191
|
0.037229413 proportion of immune cells
Interval 0.025329726 to 0.052559771
|
0.022962689 proportion of immune cells
Interval 0.012496152 to 0.035273683
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who provided samples for analysis.
Measure of expression of activation and maturation of dendritic cells in tumor (TIL).
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=14 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=13 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Activation and Maturation of Dendritic Cells - TIL
|
0.036315018 proportion of immune cells
Interval 0.029843818 to 0.072159091
|
0.053093156 proportion of immune cells
Interval 0.04276735 to 0.080816642
|
0.038510911 proportion of immune cells
Interval 0.018592677 to 0.0664646027278
|
SECONDARY outcome
Timeframe: At Week 4Population: Treated patients who provided samples for analysis.
Measure of expression of activation and maturation of dendritic cells in tumor (TIL).
Outcome measures
| Measure |
Relatlimab
n=10 Participants
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=13 Participants
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=14 Participants
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
Activation and Maturation of Dendritic Cells - TIL
|
0.088495575 proportion of immune cells
Interval 0.076190476 to 0.090909091
|
0.032432432 proportion of immune cells
Interval 0.012600229 to 0.081081081
|
0.047619048 proportion of immune cells
Interval 0.023310023 to 0.0625
|
SECONDARY outcome
Timeframe: At the time of disease progression - up to 4 yearsPopulation: No evaluable measurement data were obtained because insufficient sample material was available for analysis. Therefore, no participants were included in the analysis population for this outcome measure. No additional analyses will be performed, and no data will become available in the future.
Amount of LAG3 (cell surface molecule expressed on activated T cells) protein present in blood in patients that had previously demonstrated complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the time of disease progression - up to 4 yearsPopulation: No evaluable measurement data were obtained because insufficient sample material was available for analysis. Therefore, no participants were included in the analysis population for this outcome measure. No additional analyses will be performed, and no data will become available in the future.
Amount of LAG3 (cell surface molecule expressed on activated T cells) protein present in tumor tissue in patients that had previously demonstrated complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 2 weeks prior first study treatment, at 4 weeks, at 12 weeksPopulation: No evaluable measurement data were obtained because insufficient sample material was available for analysis. Therefore, no participants were included in the analysis population for this outcome measure. No additional analyses will be performed, and no data will become available in the future.
Level of granzyme B (a serine protease secreted cells to mediate apoptosis in target cells) in serum.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 4 weeksPopulation: No evaluable measurement data were obtained because insufficient sample material was available for analysis. Therefore, no participants were included in the analysis population for this outcome measure. No additional analyses will be performed, and no data will become available in the future.
Number of T cells present in TIL or PBMC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 weeksPopulation: No evaluable measurement data were obtained because insufficient sample material was available for analysis. Therefore, no participants were included in the analysis population for this outcome measure. No additional analyses will be performed, and no data will become available in the future.
Number of T cells present in TIL or PBMC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the time of disease progression - up to 4 yearsPopulation: No evaluable measurement data were obtained because insufficient sample material was available for analysis. Therefore, no participants were included in the analysis population for this outcome measure. No additional analyses will be performed, and no data will become available in the future.
Number of T cells present in TIL or PBMC.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksThe presence and quantity of RNA in in blood and tumor tissue.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 4 weeks post Cycle 1The presence and quantity of RNA in in blood and tumor tissue.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At week 16 (12 weeks post combination treatment (3 cycles)The presence and quantity of RNA in in blood and tumor tissue.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of disease progression - up to 4 yearsThe presence and quantity of RNA in in blood and tumor tissue in patients that had previously demonstrated complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
Outcome data not reported
Adverse Events
Relatlimab
Serious events: 6 serious events
Other events: 14 other events
Deaths: 8 deaths
Nivolumab
Serious events: 9 serious events
Other events: 15 other events
Deaths: 7 deaths
Relatlimab + Nivolumab
Serious events: 7 serious events
Other events: 14 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Relatlimab
n=14 participants at risk
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=15 participants at risk
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=14 participants at risk
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Anemia
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Hemolysis
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
CARDIAC DISORDERS
Myocarditis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
ENDOCRINE DISORDERS
Adrenal insufficiency
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Abdominal pain
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Diarrhea
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Nausea
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Pancreatitis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Small intestinal obstruction
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Vomiting
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Death NOS
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Fatigue
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
systemic inflammatory response syndrome
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Pain
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
IMMUNE SYSTEM DISORDERS
Allergic reaction
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
IMMUNE SYSTEM DISORDERS
hepatitis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
IMMUNE SYSTEM DISORDERS
systemic inflammatory response syndrome
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Encephalitis infection
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
systemic inflammatory response syndrome
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Lung infection
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
Fall
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
Hip fracture
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Cardiac troponin I increased
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Platelet count decreased
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hyperglycemia
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypoglycemia
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hyponatremia
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Ataxia
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Encephalopathy
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Intracranial hemorrhage
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Lethargy
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
myasthenic like process
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Seizure
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Stroke
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Transient ischemic attacks
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
PSYCHIATRIC DISORDERS
Confusion
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Dyspnea
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
Other adverse events
| Measure |
Relatlimab
n=14 participants at risk
Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1).
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Relatlimab: Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
|
Nivolumab
n=15 participants at risk
Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks.
Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.
Nivolumab: Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
|
Relatlimab + Nivolumab
n=14 participants at risk
Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.
Relatlimab + Nivolumab: Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
|
|---|---|---|---|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Eosinophilia
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Hemolysis
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Anemia
|
64.3%
9/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
53.3%
8/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
64.3%
9/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Leukocytosis
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Leukocytosis elevated white blood cell count
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Lymph node pain
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
CARDIAC DISORDERS
Atrial fibrillation
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
CARDIAC DISORDERS
Atrioventricular block first degree
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
CARDIAC DISORDERS
Myocardial infarction
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
CARDIAC DISORDERS
Myocarditis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
CARDIAC DISORDERS
Sinus bradycardia
|
42.9%
6/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
42.9%
6/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
CARDIAC DISORDERS
Sinus tachycardia
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
EAR AND LABYRINTH DISORDERS
Hearing impaired
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
EAR AND LABYRINTH DISORDERS
Tinnitus
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
EAR AND LABYRINTH DISORDERS
Vestibular disorder
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
ENDOCRINE DISORDERS
Adrenal insufficiency
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
ENDOCRINE DISORDERS
Endocrine disorders - Other, specify decreased ft3
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
ENDOCRINE DISORDERS
Endocrine disorders - Other, specify decreased ft4
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
ENDOCRINE DISORDERS
Endocrine disorders - Other, specify diabetes
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
ENDOCRINE DISORDERS
Hyperthyroidism
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
ENDOCRINE DISORDERS
Hypoparathyroidism
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
ENDOCRINE DISORDERS
Hypothyroidism
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
EYE DISORDERS
Blurred vision
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
EYE DISORDERS
Blurred vision visual disturbance (fuzzy)
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Abdominal pain
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Colitis
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Constipation
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Constipation intermittent
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Diarrhea
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
40.0%
6/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Diarrhea intermittent
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Dry mouth
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Dyspepsia
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Dysphagia
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Gastric hemorrhage
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Gastric ulcer
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Nausea
|
57.1%
8/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
46.7%
7/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
57.1%
8/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Nausea intermittent
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Pancreatitis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Small intestinal obstruction
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Toothache
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Vomiting
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GASTROINTESTINAL DISORDERS
Vomiting intermittent
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Chills
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Death NOS
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Edema limbs
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Edema limbs edema (legs and hands)
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Fatigue
|
78.6%
11/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
60.0%
9/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
78.6%
11/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Fever
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Flu like symptoms
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Gait disturbance
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
General disorders and administration siteconditions - Other, specify back pain (lower)
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
systemic inflammatory response syndrome
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Generalized edema
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Localized edema
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Non-cardiac chest pain
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Pain
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Pain pain (back)
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
GENERAL DISORDERS
Pain tumor pain, sternum
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
HEPATOBILIARY DISORDERS
Hepatobiliary disorders - Other, specify transaminitis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
IMMUNE SYSTEM DISORDERS
Allergic reaction
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
IMMUNE SYSTEM DISORDERS
Immune system disorders - Other, specify hepatitis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
IMMUNE SYSTEM DISORDERS
Immune system disorders - Other, specify systemic inflammatory response syndrome
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Conjunctivitis
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Encephalitis infection
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Herpes simplex reactivation
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Infections and infestations - Other, specify systemic inflammatory response syndrome
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Lung infection
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
CPK increased
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Mucosal infection
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Papulopustular rash
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Rhinitis infective
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Shingles
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Sinusitis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Skin infection
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Small intestine infection
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Thrush
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Tooth infection
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Upper respiratory infection
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Urinary tract infection
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INFECTIONS AND INFESTATIONS
Vaginal infection
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
Fall
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
Hip fracture
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
Infusion related reaction
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Activated partial thromboplastin time prolonged
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Alanine aminotransferase increased
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Alkaline phosphatase increased
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Aspartate aminotransferase increased
|
42.9%
6/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
42.9%
6/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Blood bilirubin increased
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Blood lactate dehydrogenase increased
|
57.1%
8/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
60.0%
9/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
57.1%
8/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Cardiac troponin I increased
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Cholesterol high
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Creatinine increased
|
42.9%
6/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
42.9%
6/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Electrocardiogram QT corrected intervalprolonged
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Electrocardiogram T wave abnormal
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Hemoglobin increased
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
INR increased
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Investigations - Other, specify creatinine clearance decreased
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Investigations - Other, specify protein decreased
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Investigations - Other, specify serum protein decreased
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Investigations - Other, specify white blood cell count increased
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Lipase increased
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Lymphocyte count decreased
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
40.0%
6/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Neutrophil count decreased
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
40.0%
6/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Platelet count decreased
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
33.3%
5/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Serum amylase increased
|
42.9%
6/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
42.9%
6/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Thyroid stimulating hormone increased
|
42.9%
6/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
42.9%
6/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Weight gain
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
Weight loss
|
57.1%
8/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
57.1%
8/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
INVESTIGATIONS
White blood cell decreased
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Anorexia
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Dehydration
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypercalcemia
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hyperglycemia
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
53.3%
8/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hyperkalemia
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypermagnesemia
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypernatremia
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hyperphosphatemia
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypertriglyceridemia
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypoalbuminemia
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypocalcemia
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypoglycemia
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypokalemia
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypomagnesemia
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
26.7%
4/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hyponatremia
|
78.6%
11/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
60.0%
9/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
78.6%
11/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypophosphatemia
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
33.3%
5/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Metabolism and nutrition disorders - Other,specify decreased protein
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Metabolism and nutrition disorders - Other,specify hypo-osmolality
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Metabolism and nutrition disorders - Other,specify increased lactic acid
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
METABOLISM AND NUTRITION DISORDERS
Obesity
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Arthralgia
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
35.7%
5/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Back pain
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Buttock pain
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Generalized muscle weakness
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Muscle cramp
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Muscle weakness lower limb
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Muscle weakness upper limb
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Myalgia
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Myositis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Pain in extremity
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Pain in extremity acute pain, r.u.e
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Amnesia
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Ataxia
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Cognitive disturbance difficulty identifying particular words while reading
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Concentration impairment decreased mental acuity
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Dizziness
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Dysarthria
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Dysgeusia
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Dysphasia speech delayed
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Encephalopathy
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Headache
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Headache intermittent
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Intracranial hemorrhage
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Lethargy
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Nervous system disorders - Other, specify myasthenic like process
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Paresthesia
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Seizure
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Stroke
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Syncope
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
NERVOUS SYSTEM DISORDERS
Transient ischemic attacks
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
PSYCHIATRIC DISORDERS
Anxiety
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
PSYCHIATRIC DISORDERS
Confusion
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
PSYCHIATRIC DISORDERS
Confusion intermittent
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
PSYCHIATRIC DISORDERS
Depression
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
PSYCHIATRIC DISORDERS
Hallucinations
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
PSYCHIATRIC DISORDERS
Insomnia
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RENAL AND URINARY DISORDERS
Acute kidney injury
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RENAL AND URINARY DISORDERS
Chronic kidney disease
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RENAL AND URINARY DISORDERS
Dysuria
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RENAL AND URINARY DISORDERS
Glucosuria
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RENAL AND URINARY DISORDERS
Hematuria
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RENAL AND URINARY DISORDERS
Proteinuria
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RENAL AND URINARY DISORDERS
Urinary frequency polyuria
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
Vaginal hemorrhage
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Allergic rhinitis
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Apnea
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Cough
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
21.4%
3/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Dyspnea
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Epistaxis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Hypoxia
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Nasal congestion
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Pleuritic pain
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Pneumonitis
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Respiratory, thoracic and mediastinal disorders -Other, specify hemoptysis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Respiratory, thoracic and mediastinal disorders -Other, specify shortness of breath
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Sore throat
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Wheezing
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Alopecia
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Bullous dermatitis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Dry skin
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Eczema
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Hyperhidrosis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Pain of skin
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Pruritus
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
13.3%
2/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rash acneiform
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
7.1%
1/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rash maculo-papular
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Skin and subcutaneous tissue disorders - Other,specify acrocyanosis
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Skin hyperpigmentation
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Skin hypopigmentation
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Skin ulceration
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
VASCULAR DISORDERS
Flushing
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
VASCULAR DISORDERS
Hypertension
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
20.0%
3/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
28.6%
4/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
VASCULAR DISORDERS
Hypotension
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
6.7%
1/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
14.3%
2/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
|
VASCULAR DISORDERS
Thromboembolic event dural venous sinus thrombosis, treated with rivaroxaban
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/15 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
0.00%
0/14 • Adverse Events Data, collected for 5 years, 4 months: Relatlimab Arm: combined data for all treatment cycles Nivolumab Arm: combined data for all treatment cycles Relatlimab + Nivolumab Arm: combined data for all treatment cycles All-Cause Mortality - data collected for up to 6 years from patient randomization.
The Adverse Events for each group include all events for all cycles of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place