Advanced Cancer
Conditions
Brief summary
The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer
Interventions
BIOLOGICALNivolumab
Specified Dose on Specified Days
BIOLOGICALIpilimumab
Specified Dose on Specified Days
BIOLOGICALRelatlimab
Specified Dose on Specified Days
DRUGBMS-986205
Specified Dose on Specified Days
DRUGBMS-813160
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced Renal Cell Carcinoma * Must have at least 1 lesion with measurable disease * Life expectancy of at least 3 months * Karnofsky Performance Status (KPS) must be =\>70%
Exclusion criteria
* Patients/subjects with suspected or known central nervous system metastases unless adequately treated * Patients/subjects with autoimmune disease * Patients/subjects who need daily oxygen therapy Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Per Investigator | From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks) | 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. |
| Median Duration of Response (DOR) Per Investigator | 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) | 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 |
| Progression Free Survival Rate (PFSR) at 24 Weeks. | 24 weeks after first treatment dose. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died | From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) | Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing. |
| Number of Participants With Abnormal Thyroid Test Results - Track 1 | From first dose to 30 days after last dose of study therapy (approximately 108 weeks) | 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. |
| Number of Participants With Adverse Events (AEs) | From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) | 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. |
| Number of Participants With Abnormal Hepatic Test Results - Track 1 | From first dose to 30 days after last dose of study therapy (approximately 108 weeks) | 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 |
| Number of Participants With Abnormal Hepatic Test Results - Track 2 | From first dose to 30 days after last dose of study therapy (approximately 108 weeks) | 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 |
| Number of Participants With Abnormal Thyroid Test Results - Track 2 | From first dose to 30 days after last dose of study therapy (approximately 108 weeks) | 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 |
| Number of Participants With Serious Adverse Events (SAEs) | From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) | 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 |
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation | From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) | 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. |
Countries
Australia, Austria, Canada, Israel, Italy, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) 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. | 65 |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) 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. | 56 |
| Arm 3: Nivolumab Plus BMS-986205 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. | 26 |
| Arm 4: Nivolumab Plus BMS-813160 150 mg 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. | 17 |
| Arm 5: Nivolumab Plus BMS-813160 300mg 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. | 18 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Pre-Treatment | Other Reasons | 0 | 1 | 0 | 0 | 1 |
| Pre-Treatment | Participant Withdrew Consent | 0 | 0 | 1 | 0 | 1 |
| Track 1 | Administrative Reason by Sponsor | 0 | 1 | 0 | 0 | 0 |
| Track 1 | Adverse Event Unrelated to Study Drug | 1 | 1 | 0 | 0 | 0 |
| Track 1 | Disease Progression | 15 | 17 | 0 | 0 | 0 |
| Track 1 | Participant no Longer Met Study Criteria | 1 | 0 | 0 | 0 | 0 |
| Track 1 | Participant Requested to Discontinue Study Treatment | 1 | 0 | 0 | 0 | 0 |
| Track 1 | Study Drug Toxicity | 5 | 3 | 0 | 0 | 0 |
| Track 2 | Adverse Event Unrelated to Study Drug | 4 | 0 | 0 | 1 | 1 |
| Track 2 | Death | 0 | 0 | 1 | 0 | 1 |
| Track 2 | Disease Progression | 33 | 26 | 19 | 16 | 15 |
| Track 2 | Other Reasons | 0 | 0 | 1 | 0 | 1 |
| Track 2 | Participant Requested to Discontinue Study Treatment | 0 | 0 | 2 | 1 | 2 |
| Track 2 | Participant Withdrew Consent | 1 | 2 | 3 | 1 | 1 |
| Track 2 | Study Drug Toxicity | 4 | 1 | 4 | 1 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 15 Participants | 10 Participants | 5 Participants | 7 Participants | 62 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 41 Participants | 16 Participants | 12 Participants | 11 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Track 2 Hispanic or Latino | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Track 2 Not Hispanic or Latino | 37 Participants | 34 Participants | 19 Participants | 12 Participants | 10 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Track 2 Unknown or Not Reported | 25 Participants | 20 Participants | 5 Participants | 4 Participants | 8 Participants | 62 Participants |
| Race/Ethnicity, Customized Asian Indian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian Other | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Chinese | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 62 Participants | 52 Participants | 23 Participants | 14 Participants | 17 Participants | 168 Participants |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 6 Participants | 4 Participants | 9 Participants | 49 Participants |
| Sex: Female, Male Male | 51 Participants | 40 Participants | 20 Participants | 13 Participants | 9 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 12 / 30 | 15 / 31 | 27 / 46 | 17 / 32 | 13 / 32 | 10 / 21 | 13 / 24 |
| other Total, other adverse events | 28 / 30 | 29 / 30 | 42 / 46 | 31 / 32 | 29 / 31 | 18 / 21 | 17 / 22 |
| serious Total, serious adverse events | 17 / 30 | 15 / 30 | 28 / 46 | 16 / 32 | 16 / 31 | 9 / 21 | 15 / 22 |
Outcome results
Primary
Median Duration of Response (DOR) Per Investigator
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)
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Median Duration of Response (DOR) Per Investigator | Track 1 | NA Weeks |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Median Duration of Response (DOR) Per Investigator | Track 2 | 68.00 Weeks |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Median Duration of Response (DOR) Per Investigator | Track 1 | 32.57 Weeks |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Median Duration of Response (DOR) Per Investigator | Track 2 | 99.4 Weeks |
| Arm 3: Nivolumab Plus BMS-986205 | Median Duration of Response (DOR) Per Investigator | Track 2 | NA Weeks |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Median Duration of Response (DOR) Per Investigator | Track 2 | NA Weeks |
Primary
Objective Response Rate (ORR) Per Investigator
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)
Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Objective Response Rate (ORR) Per Investigator | Track 1 | 20 Percent of participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Objective Response Rate (ORR) Per Investigator | Track 2 | 17.4 Percent of participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Objective Response Rate (ORR) Per Investigator | Track 2 | 3.1 Percent of participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Objective Response Rate (ORR) Per Investigator | Track 1 | 30 Percent of participants |
| Arm 3: Nivolumab Plus BMS-986205 | Objective Response Rate (ORR) Per Investigator | Track 2 | 3.2 Percent of participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Objective Response Rate (ORR) Per Investigator | Track 2 | 9.5 Percent of participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Objective Response Rate (ORR) Per Investigator | Track 2 | 0.0 Percent of participants |
Primary
Progression Free Survival Rate (PFSR) at 24 Weeks.
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.
Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Progression Free Survival Rate (PFSR) at 24 Weeks. | Track 2 | 0.432 Proportion of participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Progression Free Survival Rate (PFSR) at 24 Weeks. | Track 1 | 0.491 Proportion of participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Progression Free Survival Rate (PFSR) at 24 Weeks. | Track 2 | 0.194 Proportion of participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Progression Free Survival Rate (PFSR) at 24 Weeks. | Track 1 | 0.429 Proportion of participants |
| Arm 3: Nivolumab Plus BMS-986205 | Progression Free Survival Rate (PFSR) at 24 Weeks. | Track 2 | 0.278 Proportion of participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Progression Free Survival Rate (PFSR) at 24 Weeks. | Track 2 | 0.468 Proportion of participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Progression Free Survival Rate (PFSR) at 24 Weeks. | Track 2 | NA Proportion of participants |
Secondary
Number of Participants Who Died
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)
Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants Who Died | Track 2 | 27 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants Who Died | Track 1 | 12 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants Who Died | Track 2 | 17 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants Who Died | Track 1 | 15 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants Who Died | Track 2 | 13 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants Who Died | Track 2 | 10 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants Who Died | Track 2 | 13 Participants |
Secondary
Number of Participants With Abnormal Hepatic Test Results - Track 1
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)
Population: All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST > 3XULN | 2 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST> 10XULN | 0 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST> 5XULN | 1 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST > 20XULN | 0 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST > 20XULN | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST> 5XULN | 2 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST > 3XULN | 4 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST> 10XULN | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST > 20XULN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST > 3XULN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST> 5XULN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST> 10XULN | 00 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 1 | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST> 10XULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST> 5XULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST > 3XULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST > 20XULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST> 10XULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST> 5XULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST > 3XULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 1 | ALT OR AST > 20XULN | 0 Participants |
Secondary
Number of Participants With Abnormal Hepatic Test Results - Track 2
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)
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST > 3XULN | 3 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST > 20XULN | 0 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST> 5XULN | 2 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | TOTAL BILIRUBIN > 2XULN | 2 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST> 10XULN | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST> 10XULN | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST> 5XULN | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST > 20XULN | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST > 3XULN | 1 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST > 3XULN | 1 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST> 5XULN | 1 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST> 10XULN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST > 20XULN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Hepatic Test Results - Track 2 | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST> 10XULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST> 5XULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST > 3XULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST > 20XULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST > 20XULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST> 5XULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST> 10XULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Hepatic Test Results - Track 2 | ALT OR AST > 3XULN | 0 Participants |
Secondary
Number of Participants With Abnormal Thyroid Test Results - Track 1
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)
Population: All treated participants with at least one on-treatment TSH measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 3 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH < LLN WITH FT3/FT4 TEST MISSING | 5 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 3 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 2 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 3 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN WITH TSH <= ULN AT BASELINE | 5 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN | 8 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH TSH >= LLN AT BASELINE | 9 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH < LLN | 10 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN WITH TSH <= ULN AT BASELINE | 8 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN | 8 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 3 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN WITH FT3/FT4 TEST MISSING | 3 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH < LLN | 5 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH TSH >= LLN AT BASELINE | 5 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH < LLN WITH FT3/FT4 TEST MISSING | 4 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH < LLN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN WITH TSH <= ULN AT BASELINE | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH TSH >= LLN AT BASELINE | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN WITH TSH <= ULN AT BASELINE | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH < LLN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH TSH >= LLN AT BASELINE | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH < LLN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH TSH >= LLN AT BASELINE | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 1 | TSH > ULN WITH TSH <= ULN AT BASELINE | 0 Participants |
Secondary
Number of Participants With Abnormal Thyroid Test Results - Track 2
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)
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 5 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH TSH >= LLN AT BASELINE | 2 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH < LLN WITH FT3/FT4 TEST MISSING | 3 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH < LLN | 4 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN WITH FT3/FT4 TEST MISSING | 4 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 5 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN WITH TSH <= ULN AT BASELINE | 8 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN | 14 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH < LLN | 5 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH < LLN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH TSH >= LLN AT BASELINE | 4 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN | 14 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 3 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN WITH TSH <= ULN AT BASELINE | 6 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 3 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 4 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN WITH FT3/FT4 TEST MISSING | 7 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN | 6 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 3 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH < LLN | 2 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 1 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN WITH TSH <= ULN AT BASELINE | 3 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH TSH >= LLN AT BASELINE | 2 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN | 3 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN WITH TSH <= ULN AT BASELINE | 2 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 1 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH < LLN | 2 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN WITH TSH <= ULN AT BASELINE | 2 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH > ULN | 4 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 3 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH <LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Abnormal Thyroid Test Results - Track 2 | TSH < LLN | 1 Participants |
Secondary
Number of Participants With Adverse Events (AEs)
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)
Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Adverse Events (AEs) | Track 2 | 45 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Adverse Events (AEs) | Track 1 | 29 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Adverse Events (AEs) | Track 2 | 32 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Adverse Events (AEs) | Track 1 | 30 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Adverse Events (AEs) | Track 2 | 31 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Adverse Events (AEs) | Track 2 | 19 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Adverse Events (AEs) | Track 2 | 21 Participants |
Secondary
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
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)
Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | Track 2 | 10 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | Track 1 | 7 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | Track 2 | 3 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | Track 1 | 7 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | Track 2 | 6 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | Track 2 | 2 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | Track 2 | 4 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
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)
Population: All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Serious Adverse Events (SAEs) | Track 2 | 28 Participants |
| Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Number of Participants With Serious Adverse Events (SAEs) | Track 1 | 17 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Serious Adverse Events (SAEs) | Track 1 | 15 Participants |
| Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Number of Participants With Serious Adverse Events (SAEs) | Track 2 | 16 Participants |
| Arm 3: Nivolumab Plus BMS-986205 | Number of Participants With Serious Adverse Events (SAEs) | Track 2 | 16 Participants |
| Arm 4: Nivolumab Plus BMS-813160 150 mg | Number of Participants With Serious Adverse Events (SAEs) | Track 2 | 9 Participants |
| Arm 5: Nivolumab Plus BMS-813160 300mg | Number of Participants With Serious Adverse Events (SAEs) | Track 2 | 15 Participants |