We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma (FRACTION-RCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02996110
Recruitment Status : Completed
First Posted : December 19, 2016
Results First Posted : December 19, 2022
Last Update Posted : December 19, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Cancer
Interventions Biological: Nivolumab
Biological: Ipilimumab
Biological: Relatlimab
Drug: BMS-986205
Drug: BMS-813160
Enrollment 182
Recruitment Details  
Pre-assignment Details Of the 178 participants that were treated, 60 were initially randomized to Track 1 and 118 were initially randomized to Track 2. The 152 participants that started treatment in Track 2 include the total number of participants that received treatment in each arm which incorporates the 35 participants from Track 1 or 2 that were re-randomized to receive a different treatment combination in Track 2.
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Period Title: Pre-Treatment
Started [1] 65 56 26 17 18
Completed [2] 65 55 25 17 16
Not Completed 0 1 1 0 2
Reason Not Completed
Other Reasons             0             1             0             0             1
Participant Withdrew Consent             0             0             1             0             1
[1]
Initial Randomization
[2]
Continuing Into Treatment Period
Period Title: Track 1
Started 30 30 0 0 0
Re-Randomized to Track 2 5 6 0 0 0
Completed 7 8 0 0 0
Not Completed 23 22 0 0 0
Reason Not Completed
Disease Progression             15             17             0             0             0
Adverse Event Unrelated to Study Drug             1             1             0             0             0
Study Drug Toxicity             5             3             0             0             0
Participant Requested to Discontinue Study Treatment             1             0             0             0             0
Administrative Reason by Sponsor             0             1             0             0             0
Participant no Longer Met Study Criteria             1             0             0             0             0
Period Title: Track 2
Started 46 32 31 21 22
No Pre-Randomization 35 25 25 17 16
Re-Randomized From Track 1 Nivolumab + Relatlimab 2 0 2 1 1
Re-Randomized From Track 1 Nivolumab + Ipilimumab 0 3 1 1 0
Re-Randomized From Track 2 Nivolumab + Relatlimab 7 0 2 0 1
Re-Randomized From Track 2 Nivolumab + BMS986205 2 2 0 1 2
Previously Un-Treated But Re-Randomized 0 0 0 1 0
Re-Randomized From Track 2 Nivolumab + Ipilimumab 0 2 1 0 2
Completed 4 3 1 1 1
Not Completed 42 29 30 20 21
Reason Not Completed
Disease Progression             33             26             19             16             15
Adverse Event Unrelated to Study Drug             4             0             0             1             1
Death             0             0             1             0             1
Study Drug Toxicity             4             1             4             1             0
Participant Requested to Discontinue Study Treatment             0             0             2             1             2
Participant Withdrew Consent             1             2             3             1             1
Other Reasons             0             0             1             0             1
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg Total
Hide Arm/Group Description Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Total of all reporting groups
Overall Number of Baseline Participants 65 56 26 17 18 182
Hide Baseline Analysis Population Description
Arms 1 and 2 take into account both Track 1 and Track 2 participants as well as those rerandomized to the respective arms in Track 2.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 56 participants 26 participants 17 participants 18 participants 182 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
  61.5%
41
  73.2%
16
  61.5%
12
  70.6%
11
  61.1%
120
  65.9%
>=65 years
25
  38.5%
15
  26.8%
10
  38.5%
5
  29.4%
7
  38.9%
62
  34.1%
[1]
Measure Analysis Population Description: The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 56 participants 26 participants 17 participants 18 participants 182 participants
Female
14
  21.5%
16
  28.6%
6
  23.1%
4
  23.5%
9
  50.0%
49
  26.9%
Male
51
  78.5%
40
  71.4%
20
  76.9%
13
  76.5%
9
  50.0%
133
  73.1%
[1]
Measure Analysis Population Description: The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Track 2 Number Analyzed 65 participants 56 participants 26 participants 17 participants 18 participants 182 participants
Hispanic or Latino
3
   4.6%
2
   3.6%
2
   7.7%
1
   5.9%
0
   0.0%
8
   4.4%
Not Hispanic or Latino
37
  56.9%
34
  60.7%
19
  73.1%
12
  70.6%
10
  55.6%
112
  61.5%
Unknown or Not Reported
25
  38.5%
20
  35.7%
5
  19.2%
4
  23.5%
8
  44.4%
62
  34.1%
[1]
Measure Analysis Population Description: The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 65 participants 56 participants 26 participants 17 participants 18 participants 182 participants
White 62 52 23 14 17 168
Asian Indian 1 0 0 0 0 1
Chinese 0 1 0 0 0 1
Asian Other 1 1 0 0 0 2
Other 1 2 2 2 0 7
Black or African American 0 0 1 1 1 3
[1]
Measure Analysis Population Description: The analysis population consists of all participants treated (including those re-randomized) in each Arm.
1.Primary Outcome
Title Objective Response Rate (ORR) Per Investigator
Hide Description

ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).

BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.

For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.

CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm.

PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.

CR+PR, confidence interval based on Clopper and Pearson method.
Time Frame From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 76 62 31 21 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
Track 1 Number Analyzed 30 participants 30 participants 0 participants 0 participants 0 participants
20
(7.7 to 38.6)
30
(14.7 to 49.4)
Track 2 Number Analyzed 46 participants 32 participants 31 participants 21 participants 22 participants
17.4
(7.8 to 31.4)
3.1
(0.1 to 16.2)
3.2
(0.1 to 16.7)
9.5
(1.2 to 30.4)
0.0
(0.0 to 15.4)
2.Primary Outcome
Title Median Duration of Response (DOR) Per Investigator
Hide Description

Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.

Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Median computed using Kaplan -Meier method
Time Frame From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a best overall response of CR or PR. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 14 10 1 2 0
Median (Full Range)
Unit of Measure: Weeks
Track 1 Number Analyzed 6 participants 9 participants 0 participants 0 participants 0 participants
NA [1] 
(33.4 to 139.9)
32.57
(0.1 to 52.6)
Track 2 Number Analyzed 8 participants 1 participants 1 participants 2 participants 0 participants
68.00
(0.1 to 117.6)
99.4
(99.4 to 99.4)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
Insufficient number of participants with events. Five of the 6 participants received subsequent therapy prior to progression or death, thus their DOR was censored at the last tumor assessment.
[2]
Insufficient number of participants with events
3.Primary Outcome
Title Progression Free Survival Rate (PFSR) at 24 Weeks.
Hide Description

The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.

Progressive Disease (PD) is 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).

Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula
Time Frame 24 weeks after first treatment dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 76 62 31 21 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
Track 1 Number Analyzed 30 participants 30 participants 0 participants 0 participants 0 participants
0.491
(0.294 to 0.661)
0.429
(0.246 to 0.600)
Track 2 Number Analyzed 46 participants 32 participants 31 participants 21 participants 22 participants
0.432
(0.277 to 0.577)
0.194
(0.079 to 0.346)
0.278
(0.118 to 0.464)
0.468
(0.237 to 0.670)
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with events.
4.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time Frame From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 76 62 31 21 22
Measure Type: Number
Unit of Measure: Participants
Track 1 Number Analyzed 30 participants 30 participants 0 participants 0 participants 0 participants
29 30
Track 2 Number Analyzed 46 participants 32 participants 31 participants 21 participants 22 participants
45 32 31 19 21
5.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization
Time Frame From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 76 62 31 21 22
Measure Type: Number
Unit of Measure: Participants
Track 1 Number Analyzed 30 participants 30 participants 0 participants 0 participants 0 participants
17 15
Track 2 Number Analyzed 46 participants 32 participants 31 participants 21 participants 22 participants
28 16 16 9 15
6.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Hide Description An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time Frame From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 76 62 31 21 22
Measure Type: Number
Unit of Measure: Participants
Track 1 Number Analyzed 30 participants 30 participants 0 participants 0 participants 0 participants
7 7
Track 2 Number Analyzed 46 participants 32 participants 31 participants 21 participants 22 participants
10 3 6 2 4
7.Secondary Outcome
Title Number of Participants Who Died
Hide Description Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.
Time Frame From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 76 62 31 21 22
Measure Type: Number
Unit of Measure: Participants
Track 1 Number Analyzed 30 participants 30 participants 0 participants 0 participants 0 participants
12 15
Track 2 Number Analyzed 46 participants 32 participants 31 participants 21 participants 22 participants
27 17 13 10 13
8.Secondary Outcome
Title Number of Participants With Abnormal Thyroid Test Results - Track 1
Hide Description The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
Time Frame From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with at least one on-treatment TSH measurement
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 28 27 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
TSH > ULN
8
  28.6%
8
  29.6%
 0 0 0
TSH > ULN WITH TSH <= ULN AT BASELINE
5
  17.9%
8
  29.6%
 0 0 0
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
3
  10.7%
3
  11.1%
 0 0 0
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
3
  10.7%
2
   7.4%
 0 0 0
TSH > ULN WITH FT3/FT4 TEST MISSING
2
   7.1%
3
  11.1%
 0 0 0
TSH < LLN
10
  35.7%
5
  18.5%
 0 0 0
TSH <LLN WITH TSH >= LLN AT BASELINE
9
  32.1%
5
  18.5%
 0 0 0
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
3
  10.7%
0
   0.0%
 0 0 0
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
2
   7.1%
1
   3.7%
 0 0 0
TSH < LLN WITH FT3/FT4 TEST MISSING
5
  17.9%
4
  14.8%
 0 0 0
9.Secondary Outcome
Title Number of Participants With Abnormal Thyroid Test Results - Track 2
Hide Description The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Time Frame From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with at Least One On-Treatment TSH measurement. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 42 30 25 17 13
Measure Type: Count of Participants
Unit of Measure: Participants
TSH > ULN
14
  33.3%
14
  46.7%
6
  24.0%
3
  17.6%
4
  30.8%
TSH > ULN WITH TSH <= ULN AT BASELINE
8
  19.0%
6
  20.0%
3
  12.0%
2
  11.8%
2
  15.4%
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
5
  11.9%
3
  10.0%
1
   4.0%
1
   5.9%
0
   0.0%
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
5
  11.9%
4
  13.3%
3
  12.0%
2
  11.8%
3
  23.1%
TSH > ULN WITH FT3/FT4 TEST MISSING
4
   9.5%
7
  23.3%
2
   8.0%
0
   0.0%
1
   7.7%
TSH < LLN
4
   9.5%
5
  16.7%
2
   8.0%
2
  11.8%
1
   7.7%
TSH <LLN WITH TSH >= LLN AT BASELINE
2
   4.8%
4
  13.3%
1
   4.0%
2
  11.8%
1
   7.7%
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
1
   2.4%
0
   0.0%
1
   4.0%
1
   5.9%
0
   0.0%
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
0
   0.0%
3
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
TSH < LLN WITH FT3/FT4 TEST MISSING
3
   7.1%
2
   6.7%
1
   4.0%
1
   5.9%
1
   7.7%
10.Secondary Outcome
Title Number of Participants With Abnormal Hepatic Test Results - Track 1
Hide Description The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Time Frame From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 28 30 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
ALT OR AST > 3XULN
2
   7.1%
4
  13.3%
 0 0 0
ALT OR AST> 5XULN
1
   3.6%
2
   6.7%
 0 0 0
ALT OR AST> 10XULN
0
   0.0%
0
   0.0%
 00 0 0
ALT OR AST > 20XULN
0
   0.0%
0
   0.0%
 0 0 0
TOTAL BILIRUBIN > 2XULN
0
   0.0%
0
   0.0%
 0 0 0
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
0
   0.0%
0
   0.0%
 0 0 0
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
0
   0.0%
0
   0.0%
 0 0 0
11.Secondary Outcome
Title Number of Participants With Abnormal Hepatic Test Results - Track 2
Hide Description The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Time Frame From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Arm/Group Title Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) Arm 2: Nivolumab Plus Relatlimab (BMS-986016) Arm 3: Nivolumab Plus BMS-986205 Arm 4: Nivolumab Plus BMS-813160 150 mg Arm 5: Nivolumab Plus BMS-813160 300mg
Hide Arm/Group Description:
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 44 32 29 17 18
Measure Type: Count of Participants
Unit of Measure: Participants
ALT OR AST > 3XULN
3
   6.8%
1
   3.1%
1
   3.4%
0
   0.0%
0
   0.0%
ALT OR AST> 5XULN
2
   4.5%
0
   0.0%
1
   3.4%
0
   0.0%
0
   0.0%
ALT OR AST> 10XULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT OR AST > 20XULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
TOTAL BILIRUBIN > 2XULN
2
   4.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks).
Adverse Event Reporting Description The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
 
Arm/Group Title Track 1: Nivolumab Plus Ipilimumab (BMS-734016) Track 1: Nivolumab Plus Relatlimab (BMS-986016) Track 2: Nivolumab Plus Ipilimumab (BMS-734016) Track 2: Nivolumab Plus Relatlimab (BMS-986016) Track 2: Nivolumab Plus BMS-986205 Track 2: Nivolumab Plus BMS-813160 150 mg Track 2: Nivolumab Plus BMS-813160 300 mg
Hide Arm/Group Description Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
All-Cause Mortality
Track 1: Nivolumab Plus Ipilimumab (BMS-734016) Track 1: Nivolumab Plus Relatlimab (BMS-986016) Track 2: Nivolumab Plus Ipilimumab (BMS-734016) Track 2: Nivolumab Plus Relatlimab (BMS-986016) Track 2: Nivolumab Plus BMS-986205 Track 2: Nivolumab Plus BMS-813160 150 mg Track 2: Nivolumab Plus BMS-813160 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/30 (40.00%)   15/31 (48.39%)   27/46 (58.70%)   17/32 (53.13%)   13/32 (40.63%)   10/21 (47.62%)   13/24 (54.17%) 
Hide Serious Adverse Events
Track 1: Nivolumab Plus Ipilimumab (BMS-734016) Track 1: Nivolumab Plus Relatlimab (BMS-986016) Track 2: Nivolumab Plus Ipilimumab (BMS-734016) Track 2: Nivolumab Plus Relatlimab (BMS-986016) Track 2: Nivolumab Plus BMS-986205 Track 2: Nivolumab Plus BMS-813160 150 mg Track 2: Nivolumab Plus BMS-813160 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/30 (56.67%)   15/30 (50.00%)   28/46 (60.87%)   16/32 (50.00%)   16/31 (51.61%)   9/21 (42.86%)   15/22 (68.18%) 
Blood and lymphatic system disorders               
Anaemia † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Cardiac disorders               
Angina pectoris † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Atrial fibrillation † 1  1/30 (3.33%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Cardiac arrest † 1  0/30 (0.00%)  0/30 (0.00%)  2/46 (4.35%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Cardiac failure congestive † 1  1/30 (3.33%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Myocarditis † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Pericarditis † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Ventricular tachycardia † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Endocrine disorders               
Adrenal insufficiency † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Immune-mediated adrenal insufficiency † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Inappropriate antidiuretic hormone secretion † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Gastrointestinal disorders               
Abdominal pain † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Abdominal pain lower † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Colitis † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Diarrhoea † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  1/22 (4.55%) 
Enteritis † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Enterocolitis † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Gastrointestinal haemorrhage † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Large intestinal obstruction † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Lip swelling † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Lower gastrointestinal haemorrhage † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Mouth haemorrhage † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Nausea † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Oesophagitis † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Small intestinal haemorrhage † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Small intestinal obstruction † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Upper gastrointestinal haemorrhage † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Vomiting † 1  0/30 (0.00%)  2/30 (6.67%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
General disorders               
Asthenia † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Fatigue † 1  1/30 (3.33%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
General physical health deterioration † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Non-cardiac chest pain † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Pain † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Pyrexia † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Hepatobiliary disorders               
Biliary obstruction † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Cholecystitis † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Hepatotoxicity † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Infections and infestations               
Bronchitis † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  1/21 (4.76%)  0/22 (0.00%) 
Cellulitis † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Device related infection † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Epididymitis † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Pneumonia † 1  4/30 (13.33%)  0/30 (0.00%)  0/46 (0.00%)  3/32 (9.38%)  2/31 (6.45%)  0/21 (0.00%)  2/22 (9.09%) 
Pneumonia influenzal † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Pulmonary sepsis † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Sepsis † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Sialoadenitis † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Sinusitis † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Urinary tract infection † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Urosepsis † 1  1/30 (3.33%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Wound infection † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Injury, poisoning and procedural complications               
Acetabulum fracture † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Fall † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Fracture † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Post procedural haematuria † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Wound dehiscence † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  2/31 (6.45%)  0/21 (0.00%)  0/22 (0.00%) 
Investigations               
Amylase increased † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Blood alkaline phosphatase increased † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Blood creatinine increased † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Blood potassium increased † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Lipase increased † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Transaminases increased † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Metabolism and nutrition disorders               
Dehydration † 1  2/30 (6.67%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Diabetic ketoacidosis † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Failure to thrive † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Hypercalcaemia † 1  2/30 (6.67%)  3/30 (10.00%)  2/46 (4.35%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Hyperkalaemia † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Hypocalcaemia † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Hyponatraemia † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Autoimmune myositis † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Back pain † 1  0/30 (0.00%)  1/30 (3.33%)  1/46 (2.17%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Flank pain † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Groin pain † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Muscular weakness † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  2/32 (6.25%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Musculoskeletal chest pain † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Pain in extremity † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Polymyalgia rheumatica † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Bladder cancer † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Cancer pain † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  1/22 (4.55%) 
Malignant neoplasm progression † 1  2/30 (6.67%)  5/30 (16.67%)  6/46 (13.04%)  5/32 (15.63%)  3/31 (9.68%)  1/21 (4.76%)  4/22 (18.18%) 
Metastases to bone † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Metastases to central nervous system † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Metastases to lung † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Metastatic renal cell carcinoma † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Prostate cancer † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Tumour pain † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Nervous system disorders               
Aphasia † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Brain oedema † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Dizziness † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Encephalopathy † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Facial paralysis † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Immune-mediated neuropathy † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Neuralgia † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Pyramidal tract syndrome † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Seizure † 1  0/30 (0.00%)  1/30 (3.33%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Spinal cord compression † 1  0/30 (0.00%)  2/30 (6.67%)  1/46 (2.17%)  1/32 (3.13%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Renal and urinary disorders               
Acute kidney injury † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  2/21 (9.52%)  1/22 (4.55%) 
Bladder perforation † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Immune-mediated nephritis † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Oliguria † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Renal haematoma † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders               
Acute respiratory distress syndrome † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Atelectasis † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Cough † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Dyspnoea † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  1/32 (3.13%)  2/31 (6.45%)  2/21 (9.52%)  0/22 (0.00%) 
Pleural effusion † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  2/31 (6.45%)  0/21 (0.00%)  0/22 (0.00%) 
Pneumonitis † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Pneumothorax † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  1/22 (4.55%) 
Pulmonary embolism † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  2/31 (6.45%)  0/21 (0.00%)  0/22 (0.00%) 
Respiratory arrest † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Skin and subcutaneous tissue disorders               
Intertrigo † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Rash † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Vascular disorders               
Deep vein thrombosis † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Embolism † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Haematoma † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Hypotension † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Lymphoedema † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
1
Term from vocabulary, 25.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Track 1: Nivolumab Plus Ipilimumab (BMS-734016) Track 1: Nivolumab Plus Relatlimab (BMS-986016) Track 2: Nivolumab Plus Ipilimumab (BMS-734016) Track 2: Nivolumab Plus Relatlimab (BMS-986016) Track 2: Nivolumab Plus BMS-986205 Track 2: Nivolumab Plus BMS-813160 150 mg Track 2: Nivolumab Plus BMS-813160 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/30 (93.33%)   29/30 (96.67%)   42/46 (91.30%)   31/32 (96.88%)   29/31 (93.55%)   18/21 (85.71%)   17/22 (77.27%) 
Blood and lymphatic system disorders               
Anaemia † 1  8/30 (26.67%)  5/30 (16.67%)  8/46 (17.39%)  4/32 (12.50%)  4/31 (12.90%)  2/21 (9.52%)  2/22 (9.09%) 
Cardiac disorders               
Sinus tachycardia † 1  1/30 (3.33%)  1/30 (3.33%)  0/46 (0.00%)  1/32 (3.13%)  2/31 (6.45%)  0/21 (0.00%)  0/22 (0.00%) 
Ear and labyrinth disorders               
Vertigo † 1  0/30 (0.00%)  2/30 (6.67%)  1/46 (2.17%)  1/32 (3.13%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Endocrine disorders               
Hyperthyroidism † 1  4/30 (13.33%)  3/30 (10.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  1/22 (4.55%) 
Hypothyroidism † 1  4/30 (13.33%)  6/30 (20.00%)  2/46 (4.35%)  0/32 (0.00%)  3/31 (9.68%)  0/21 (0.00%)  0/22 (0.00%) 
Eye disorders               
Dry eye † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  3/32 (9.38%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Vision blurred † 1  2/30 (6.67%)  2/30 (6.67%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Gastrointestinal disorders               
Abdominal pain † 1  3/30 (10.00%)  1/30 (3.33%)  5/46 (10.87%)  4/32 (12.50%)  2/31 (6.45%)  1/21 (4.76%)  1/22 (4.55%) 
Colitis † 1  2/30 (6.67%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Constipation † 1  3/30 (10.00%)  8/30 (26.67%)  5/46 (10.87%)  12/32 (37.50%)  6/31 (19.35%)  2/21 (9.52%)  2/22 (9.09%) 
Diarrhoea † 1  6/30 (20.00%)  9/30 (30.00%)  14/46 (30.43%)  7/32 (21.88%)  5/31 (16.13%)  6/21 (28.57%)  1/22 (4.55%) 
Dry mouth † 1  1/30 (3.33%)  4/30 (13.33%)  4/46 (8.70%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Epigastric discomfort † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  2/32 (6.25%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Gastrooesophageal reflux disease † 1  0/30 (0.00%)  0/30 (0.00%)  3/46 (6.52%)  1/32 (3.13%)  2/31 (6.45%)  1/21 (4.76%)  0/22 (0.00%) 
Nausea † 1  10/30 (33.33%)  7/30 (23.33%)  14/46 (30.43%)  8/32 (25.00%)  8/31 (25.81%)  6/21 (28.57%)  4/22 (18.18%) 
Oral pain † 1  0/30 (0.00%)  0/30 (0.00%)  2/46 (4.35%)  2/32 (6.25%)  0/31 (0.00%)  2/21 (9.52%)  1/22 (4.55%) 
Stomatitis † 1  0/30 (0.00%)  0/30 (0.00%)  6/46 (13.04%)  3/32 (9.38%)  1/31 (3.23%)  4/21 (19.05%)  0/22 (0.00%) 
Vomiting † 1  5/30 (16.67%)  6/30 (20.00%)  7/46 (15.22%)  2/32 (6.25%)  6/31 (19.35%)  2/21 (9.52%)  0/22 (0.00%) 
General disorders               
Asthenia † 1  2/30 (6.67%)  0/30 (0.00%)  3/46 (6.52%)  2/32 (6.25%)  3/31 (9.68%)  2/21 (9.52%)  1/22 (4.55%) 
Chest discomfort † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  2/21 (9.52%)  0/22 (0.00%) 
Chills † 1  3/30 (10.00%)  2/30 (6.67%)  4/46 (8.70%)  3/32 (9.38%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Fatigue † 1  9/30 (30.00%)  13/30 (43.33%)  15/46 (32.61%)  11/32 (34.38%)  8/31 (25.81%)  7/21 (33.33%)  6/22 (27.27%) 
Gait disturbance † 1  1/30 (3.33%)  0/30 (0.00%)  2/46 (4.35%)  2/32 (6.25%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Mucosal inflammation † 1  1/30 (3.33%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  2/21 (9.52%)  0/22 (0.00%) 
Non-cardiac chest pain † 1  3/30 (10.00%)  1/30 (3.33%)  1/46 (2.17%)  3/32 (9.38%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Oedema peripheral † 1  4/30 (13.33%)  3/30 (10.00%)  6/46 (13.04%)  4/32 (12.50%)  5/31 (16.13%)  1/21 (4.76%)  0/22 (0.00%) 
Pyrexia † 1  5/30 (16.67%)  2/30 (6.67%)  5/46 (10.87%)  5/32 (15.63%)  2/31 (6.45%)  1/21 (4.76%)  2/22 (9.09%) 
Infections and infestations               
Bronchitis † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  2/21 (9.52%)  0/22 (0.00%) 
Conjunctivitis † 1  1/30 (3.33%)  1/30 (3.33%)  3/46 (6.52%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Gastroenteritis † 1  0/30 (0.00%)  1/30 (3.33%)  0/46 (0.00%)  3/32 (9.38%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Influenza † 1  0/30 (0.00%)  1/30 (3.33%)  1/46 (2.17%)  2/32 (6.25%)  1/31 (3.23%)  1/21 (4.76%)  1/22 (4.55%) 
Pneumonia † 1  1/30 (3.33%)  1/30 (3.33%)  0/46 (0.00%)  3/32 (9.38%)  0/31 (0.00%)  1/21 (4.76%)  1/22 (4.55%) 
Upper respiratory tract infection † 1  3/30 (10.00%)  2/30 (6.67%)  5/46 (10.87%)  4/32 (12.50%)  3/31 (9.68%)  2/21 (9.52%)  0/22 (0.00%) 
Urinary tract infection † 1  1/30 (3.33%)  0/30 (0.00%)  4/46 (8.70%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  2/22 (9.09%) 
Injury, poisoning and procedural complications               
Fall † 1  1/30 (3.33%)  4/30 (13.33%)  5/46 (10.87%)  2/32 (6.25%)  1/31 (3.23%)  1/21 (4.76%)  1/22 (4.55%) 
Procedural pain † 1  0/30 (0.00%)  3/30 (10.00%)  2/46 (4.35%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Investigations               
Alanine aminotransferase increased † 1  1/30 (3.33%)  2/30 (6.67%)  5/46 (10.87%)  1/32 (3.13%)  2/31 (6.45%)  2/21 (9.52%)  2/22 (9.09%) 
Amylase increased † 1  2/30 (6.67%)  0/30 (0.00%)  3/46 (6.52%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Aspartate aminotransferase increased † 1  1/30 (3.33%)  1/30 (3.33%)  5/46 (10.87%)  2/32 (6.25%)  3/31 (9.68%)  3/21 (14.29%)  2/22 (9.09%) 
Blood alkaline phosphatase increased † 1  1/30 (3.33%)  3/30 (10.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  1/21 (4.76%)  1/22 (4.55%) 
Blood bilirubin increased † 1  0/30 (0.00%)  0/30 (0.00%)  2/46 (4.35%)  0/32 (0.00%)  2/31 (6.45%)  0/21 (0.00%)  0/22 (0.00%) 
Blood creatinine increased † 1  5/30 (16.67%)  3/30 (10.00%)  2/46 (4.35%)  0/32 (0.00%)  3/31 (9.68%)  2/21 (9.52%)  2/22 (9.09%) 
Lipase increased † 1  4/30 (13.33%)  1/30 (3.33%)  3/46 (6.52%)  1/32 (3.13%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Weight decreased † 1  3/30 (10.00%)  1/30 (3.33%)  5/46 (10.87%)  2/32 (6.25%)  1/31 (3.23%)  1/21 (4.76%)  2/22 (9.09%) 
Metabolism and nutrition disorders               
Decreased appetite † 1  5/30 (16.67%)  5/30 (16.67%)  12/46 (26.09%)  8/32 (25.00%)  4/31 (12.90%)  5/21 (23.81%)  3/22 (13.64%) 
Hypercalcaemia † 1  4/30 (13.33%)  2/30 (6.67%)  3/46 (6.52%)  3/32 (9.38%)  1/31 (3.23%)  2/21 (9.52%)  1/22 (4.55%) 
Hyperglycaemia † 1  3/30 (10.00%)  1/30 (3.33%)  2/46 (4.35%)  1/32 (3.13%)  3/31 (9.68%)  0/21 (0.00%)  1/22 (4.55%) 
Hyperkalaemia † 1  1/30 (3.33%)  1/30 (3.33%)  3/46 (6.52%)  2/32 (6.25%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Hypoalbuminaemia † 1  2/30 (6.67%)  1/30 (3.33%)  1/46 (2.17%)  2/32 (6.25%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Hypokalaemia † 1  4/30 (13.33%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  1/31 (3.23%)  0/21 (0.00%)  1/22 (4.55%) 
Hypomagnesaemia † 1  2/30 (6.67%)  1/30 (3.33%)  0/46 (0.00%)  1/32 (3.13%)  1/31 (3.23%)  1/21 (4.76%)  0/22 (0.00%) 
Hyponatraemia † 1  1/30 (3.33%)  2/30 (6.67%)  1/46 (2.17%)  2/32 (6.25%)  2/31 (6.45%)  0/21 (0.00%)  0/22 (0.00%) 
Hypophosphataemia † 1  2/30 (6.67%)  2/30 (6.67%)  1/46 (2.17%)  1/32 (3.13%)  1/31 (3.23%)  2/21 (9.52%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia † 1  6/30 (20.00%)  1/30 (3.33%)  5/46 (10.87%)  7/32 (21.88%)  7/31 (22.58%)  2/21 (9.52%)  4/22 (18.18%) 
Back pain † 1  3/30 (10.00%)  5/30 (16.67%)  6/46 (13.04%)  7/32 (21.88%)  6/31 (19.35%)  3/21 (14.29%)  4/22 (18.18%) 
Flank pain † 1  2/30 (6.67%)  0/30 (0.00%)  1/46 (2.17%)  4/32 (12.50%)  2/31 (6.45%)  1/21 (4.76%)  0/22 (0.00%) 
Groin pain † 1  0/30 (0.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  2/31 (6.45%)  2/21 (9.52%)  1/22 (4.55%) 
Muscle spasms † 1  2/30 (6.67%)  1/30 (3.33%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  2/21 (9.52%)  0/22 (0.00%) 
Muscular weakness † 1  3/30 (10.00%)  2/30 (6.67%)  6/46 (13.04%)  2/32 (6.25%)  3/31 (9.68%)  2/21 (9.52%)  1/22 (4.55%) 
Myalgia † 1  2/30 (6.67%)  2/30 (6.67%)  1/46 (2.17%)  5/32 (15.63%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Neck pain † 1  2/30 (6.67%)  1/30 (3.33%)  2/46 (4.35%)  1/32 (3.13%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Pain in extremity † 1  3/30 (10.00%)  3/30 (10.00%)  0/46 (0.00%)  5/32 (15.63%)  4/31 (12.90%)  1/21 (4.76%)  2/22 (9.09%) 
Nervous system disorders               
Amnesia † 1  0/30 (0.00%)  0/30 (0.00%)  2/46 (4.35%)  2/32 (6.25%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Dizziness † 1  5/30 (16.67%)  3/30 (10.00%)  6/46 (13.04%)  4/32 (12.50%)  2/31 (6.45%)  3/21 (14.29%)  1/22 (4.55%) 
Dizziness postural † 1  2/30 (6.67%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Dysgeusia † 1  1/30 (3.33%)  3/30 (10.00%)  1/46 (2.17%)  0/32 (0.00%)  2/31 (6.45%)  1/21 (4.76%)  0/22 (0.00%) 
Headache † 1  4/30 (13.33%)  10/30 (33.33%)  5/46 (10.87%)  1/32 (3.13%)  2/31 (6.45%)  3/21 (14.29%)  3/22 (13.64%) 
Lethargy † 1  1/30 (3.33%)  1/30 (3.33%)  1/46 (2.17%)  0/32 (0.00%)  2/31 (6.45%)  0/21 (0.00%)  0/22 (0.00%) 
Paraesthesia † 1  1/30 (3.33%)  3/30 (10.00%)  1/46 (2.17%)  4/32 (12.50%)  1/31 (3.23%)  2/21 (9.52%)  1/22 (4.55%) 
Spinal cord compression † 1  0/30 (0.00%)  2/30 (6.67%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Taste disorder † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  3/31 (9.68%)  0/21 (0.00%)  0/22 (0.00%) 
Tremor † 1  2/30 (6.67%)  1/30 (3.33%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Psychiatric disorders               
Anxiety † 1  1/30 (3.33%)  3/30 (10.00%)  1/46 (2.17%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  1/22 (4.55%) 
Depression † 1  1/30 (3.33%)  2/30 (6.67%)  0/46 (0.00%)  0/32 (0.00%)  2/31 (6.45%)  0/21 (0.00%)  0/22 (0.00%) 
Insomnia † 1  5/30 (16.67%)  2/30 (6.67%)  4/46 (8.70%)  1/32 (3.13%)  1/31 (3.23%)  2/21 (9.52%)  0/22 (0.00%) 
Renal and urinary disorders               
Acute kidney injury † 1  3/30 (10.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/31 (3.23%)  1/21 (4.76%)  1/22 (4.55%) 
Dysuria † 1  0/30 (0.00%)  0/30 (0.00%)  3/46 (6.52%)  0/32 (0.00%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Pollakiuria † 1  2/30 (6.67%)  0/30 (0.00%)  2/46 (4.35%)  1/32 (3.13%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Urinary retention † 1  2/30 (6.67%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough † 1  11/30 (36.67%)  6/30 (20.00%)  10/46 (21.74%)  8/32 (25.00%)  6/31 (19.35%)  6/21 (28.57%)  2/22 (9.09%) 
Dysphonia † 1  2/30 (6.67%)  0/30 (0.00%)  3/46 (6.52%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  0/22 (0.00%) 
Dyspnoea † 1  7/30 (23.33%)  4/30 (13.33%)  6/46 (13.04%)  3/32 (9.38%)  7/31 (22.58%)  2/21 (9.52%)  4/22 (18.18%) 
Dyspnoea exertional † 1  2/30 (6.67%)  0/30 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  1/21 (4.76%)  1/22 (4.55%) 
Epistaxis † 1  1/30 (3.33%)  0/30 (0.00%)  2/46 (4.35%)  0/32 (0.00%)  0/31 (0.00%)  2/21 (9.52%)  0/22 (0.00%) 
Nasal congestion † 1  3/30 (10.00%)  0/30 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Oropharyngeal pain † 1  1/30 (3.33%)  4/30 (13.33%)  1/46 (2.17%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Pleural effusion † 1  2/30 (6.67%)  1/30 (3.33%)  0/46 (0.00%)  0/32 (0.00%)  3/31 (9.68%)  1/21 (4.76%)  0/22 (0.00%) 
Pleuritic pain † 1  2/30 (6.67%)  0/30 (0.00%)  1/46 (2.17%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Pneumonitis † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  2/31 (6.45%)  0/21 (0.00%)  1/22 (4.55%) 
Pneumothorax † 1  0/30 (0.00%)  2/30 (6.67%)  1/46 (2.17%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  1/22 (4.55%) 
Productive cough † 1  0/30 (0.00%)  4/30 (13.33%)  0/46 (0.00%)  1/32 (3.13%)  1/31 (3.23%)  3/21 (14.29%)  0/22 (0.00%) 
Rhinorrhoea † 1  0/30 (0.00%)  1/30 (3.33%)  1/46 (2.17%)  2/32 (6.25%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
Skin and subcutaneous tissue disorders               
Dry skin † 1  2/30 (6.67%)  1/30 (3.33%)  2/46 (4.35%)  2/32 (6.25%)  2/31 (6.45%)  0/21 (0.00%)  0/22 (0.00%) 
Erythema † 1  2/30 (6.67%)  1/30 (3.33%)  0/46 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Night sweats † 1  3/30 (10.00%)  1/30 (3.33%)  0/46 (0.00%)  3/32 (9.38%)  1/31 (3.23%)  1/21 (4.76%)  1/22 (4.55%) 
Palmar-plantar erythrodysaesthesia syndrome † 1  0/30 (0.00%)  1/30 (3.33%)  2/46 (4.35%)  1/32 (3.13%)  0/31 (0.00%)  2/21 (9.52%)  1/22 (4.55%) 
Pruritus † 1  10/30 (33.33%)  6/30 (20.00%)  10/46 (21.74%)  8/32 (25.00%)  2/31 (6.45%)  3/21 (14.29%)  1/22 (4.55%) 
Rash † 1  8/30 (26.67%)  7/30 (23.33%)  12/46 (26.09%)  7/32 (21.88%)  3/31 (9.68%)  4/21 (19.05%)  2/22 (9.09%) 
Rash maculo-papular † 1  5/30 (16.67%)  1/30 (3.33%)  2/46 (4.35%)  0/32 (0.00%)  0/31 (0.00%)  1/21 (4.76%)  1/22 (4.55%) 
Rash pruritic † 1  2/30 (6.67%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/21 (0.00%)  0/22 (0.00%) 
Rosacea † 1  0/30 (0.00%)  0/30 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  2/21 (9.52%)  0/22 (0.00%) 
Vascular disorders               
Hot flush † 1  1/30 (3.33%)  2/30 (6.67%)  1/46 (2.17%)  0/32 (0.00%)  2/31 (6.45%)  0/21 (0.00%)  0/22 (0.00%) 
Hypertension † 1  1/30 (3.33%)  2/30 (6.67%)  4/46 (8.70%)  1/32 (3.13%)  1/31 (3.23%)  2/21 (9.52%)  0/22 (0.00%) 
Hypotension † 1  1/30 (3.33%)  1/30 (3.33%)  2/46 (4.35%)  2/32 (6.25%)  1/31 (3.23%)  0/21 (0.00%)  0/22 (0.00%) 
1
Term from vocabulary, 25.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please Email
EMail: Clinical.Trials@bms.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02996110    
Other Study ID Numbers: CA018-005
2016-003082-26 ( EudraCT Number )
First Submitted: December 15, 2016
First Posted: December 19, 2016
Results First Submitted: November 18, 2022
Results First Posted: December 19, 2022
Last Update Posted: December 19, 2022