Advanced Cancer
Conditions
Brief summary
The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer
Interventions
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Specified dose on specified days
Sponsors
Study design
Eligibility
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Advanced Non Small Cell Lung Cancer (NSCLC) * Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1 * Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment * Must have at least 1 lesion with measurable disease
Exclusion criteria
* Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment * Subjects who need daily oxygen therapy * People with autoimmune disease Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From first dose to 2 years following last dose (up to 30 months) | ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track. |
| Duration of Response (DOR) | From first dose to 2 years following last dose (up to 30 months) | DOR, computed for all treated participants with a confirmed BOR of CR or PR, 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. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track. |
| Progression Free Survival Rate (PFSR) at 24 Weeks | From first dose to 24 weeks after first 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. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (\>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (\<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Death | From first dose to up to 45 months following first dose | This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame |
| Percentage of Participants Experiencing Adverse Events (AEs) | From first dose to 100 days following last dose | This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame |
| Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | From first dose to 100 days following last dose (approximately 9 months) | The following measurements will be considered laboratory abnormalities for thyroid tests: * TSH value \> ULN and * With baseline TSH value ≤ ULN * At least one T3/T4 test value \< LLN * Low TSH \< LLN and * With baseline TSH value ≥ LLN * At least one T3/T4 test value \> ULN TSH = thyroid stimulating hormone ULN=Upper Limit of Normal LLN=Lower Limit of Normal T3=Triiodothyronine T4=Thyroxine |
| Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | From first dose to 100 days following last dose (approximately 9 months) | The following measurements will be considered laboratory abnormalities for hepatic tests: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper Limit of Normal |
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 100 days following last dose | This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame |
| Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose to 100 days following last dose | This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame |
Countries
Australia, Austria, Canada, France, Italy, Spain, Switzerland, United States
Participant flow
Pre-assignment details
The total number of participants randomized and treated is 295. Each participant was assigned to 1 of 5 non-consecutive Tracks (based on previous therapy exposure and/or PD-1/PD-L1 expression). 14 of the 295 participants, after receiving initial treatment, were re-randomized to a second, different treatment (either under a different Track or within the same Track).
Participants by arm
| Arm | Count |
|---|---|
| Nivolumab Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks) | 49 |
| Nivolumab + Dasatinib Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks) | 104 |
| Nivolumab + BMS986016 Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks) | 17 |
| Nivolumab + Ipilimumab Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study | 88 |
| Nivolumab + BMS986205 Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks) | 37 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Track 1 | Adverse event unrelated to study drug | 1 | 0 | 0 | 0 | 0 |
| Track 1 | Disease progression | 20 | 1 | 0 | 1 | 0 |
| Track 1 | Other reasons | 1 | 0 | 0 | 0 | 0 |
| Track 1 | Participant request to discontinue | 1 | 0 | 0 | 0 | 0 |
| Track 1 | Study drug toxicity | 4 | 1 | 0 | 1 | 0 |
| Track 2 | Adverse event unrelated to study drug | 1 | 0 | 0 | 0 | 0 |
| Track 2 | Disease progression | 4 | 5 | 2 | 5 | 0 |
| Track 2 | Participant withdrew consent | 0 | 1 | 0 | 0 | 0 |
| Track 2 | Study drug toxicity | 1 | 2 | 0 | 2 | 0 |
| Track 3 | Adverse event unrelated to study drug | 0 | 1 | 1 | 1 | 0 |
| Track 3 | Disease progression | 0 | 24 | 13 | 14 | 0 |
| Track 3 | Other reasons | 0 | 3 | 0 | 0 | 0 |
| Track 3 | Participant request to discontinue | 0 | 2 | 0 | 0 | 0 |
| Track 3 | Participant withdrew consent | 0 | 3 | 1 | 0 | 0 |
| Track 3 | Study drug toxicity | 0 | 3 | 0 | 1 | 0 |
| Track 4 | Adverse event unrelated to study drug | 0 | 5 | 0 | 0 | 0 |
| Track 4 | Death | 0 | 0 | 0 | 1 | 0 |
| Track 4 | Disease progression | 0 | 33 | 0 | 32 | 0 |
| Track 4 | Other reasons | 0 | 5 | 0 | 3 | 0 |
| Track 4 | Participant request to discontinue | 0 | 1 | 0 | 1 | 0 |
| Track 4 | Participant withdrew consent | 0 | 1 | 0 | 0 | 0 |
| Track 4 | Study drug toxicity | 0 | 6 | 0 | 5 | 0 |
| Track 5 | Adverse event unrelated to study drug | 0 | 0 | 0 | 0 | 2 |
| Track 5 | Disease progression | 0 | 0 | 0 | 0 | 34 |
| Track 5 | Other reasons | 0 | 0 | 0 | 0 | 2 |
| Track 5 | Participant request to discontinue | 0 | 0 | 0 | 0 | 3 |
| Track 5 | Study drug toxicity | 0 | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Nivolumab | Nivolumab + Dasatinib | Nivolumab + BMS986016 | Nivolumab + Ipilimumab | Nivolumab + BMS986205 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 64.5 Years STANDARD_DEVIATION 10.27 | 63.6 Years STANDARD_DEVIATION 9.25 | 66.6 Years STANDARD_DEVIATION 9.17 | 62.3 Years STANDARD_DEVIATION 9.04 | 63.6 Years STANDARD_DEVIATION 7.89 | 63.5 Years STANDARD_DEVIATION 9.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 5 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 65 Participants | 17 Participants | 58 Participants | 27 Participants | 192 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 23 Participants | 37 Participants | 0 Participants | 25 Participants | 9 Participants | 94 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 2 Participants | 2 Participants | 3 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 1 Participants | 6 Participants | 6 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 0 Participants | 2 Participants | 2 Participants | 15 Participants |
| Race (NIH/OMB) White | 42 Participants | 85 Participants | 14 Participants | 78 Participants | 26 Participants | 245 Participants |
| Sex: Female, Male Female | 21 Participants | 34 Participants | 8 Participants | 38 Participants | 21 Participants | 122 Participants |
| Sex: Female, Male Male | 28 Participants | 70 Participants | 9 Participants | 50 Participants | 16 Participants | 173 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 | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 22 / 40 | 2 / 4 | 1 / 3 | 6 / 9 | 4 / 8 | 2 / 2 | 6 / 12 | 20 / 41 | 10 / 16 | 9 / 18 | 33 / 53 | 27 / 60 | 27 / 43 |
| other Total, other adverse events | 38 / 40 | 4 / 4 | 3 / 3 | 9 / 9 | 7 / 8 | 2 / 2 | 12 / 12 | 38 / 41 | 16 / 16 | 17 / 18 | 50 / 53 | 59 / 60 | 41 / 43 |
| serious Total, serious adverse events | 24 / 40 | 2 / 4 | 0 / 3 | 4 / 9 | 5 / 8 | 2 / 2 | 5 / 12 | 17 / 41 | 9 / 16 | 10 / 18 | 33 / 53 | 39 / 60 | 26 / 43 |
Outcome results
Duration of Response (DOR)
DOR, computed for all treated participants with a confirmed BOR of CR or PR, 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. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Time frame: From first dose to 2 years following last dose (up to 30 months)
Population: All participants with a confirmed best overall response (BOR) of Complete Response (CR) or Partial Response (PR).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nivolumab | Duration of Response (DOR) | Study Track 1 | 12.81 Months |
| Nivolumab + Dasatinib | Duration of Response (DOR) | Study Track 4 | NA Months |
| Nivolumab + Dasatinib | Duration of Response (DOR) | Study Track 1 | 8.57 Months |
| Nivolumab + Dasatinib | Duration of Response (DOR) | Study Track 3 | NA Months |
| Nivolumab + Ipilimumab | Duration of Response (DOR) | Study Track 3 | NA Months |
| Nivolumab + Ipilimumab | Duration of Response (DOR) | Study Track 2 | NA Months |
| Nivolumab + Ipilimumab | Duration of Response (DOR) | Study Track 4 | 12.65 Months |
| Nivolumab + BMS986205 | Duration of Response (DOR) | Study Track 5 | 3.75 Months |
Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Time frame: From first dose to 2 years following last dose (up to 30 months)
Population: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab | Objective Response Rate (ORR) | Study Track 2 | 0 Percent of Participants |
| Nivolumab | Objective Response Rate (ORR) | Study Track 1 | 17.5 Percent of Participants |
| Nivolumab + Dasatinib | Objective Response Rate (ORR) | Study Track 4 | 1.9 Percent of Participants |
| Nivolumab + Dasatinib | Objective Response Rate (ORR) | Study Track 2 | 0 Percent of Participants |
| Nivolumab + Dasatinib | Objective Response Rate (ORR) | Study Track 3 | 2.4 Percent of Participants |
| Nivolumab + Dasatinib | Objective Response Rate (ORR) | Study Track 1 | 25.0 Percent of Participants |
| Nivolumab + BMS986016 | Objective Response Rate (ORR) | Study Track 2 | 0 Percent of Participants |
| Nivolumab + BMS986016 | Objective Response Rate (ORR) | Study Track 3 | 0 Percent of Participants |
| Nivolumab + Ipilimumab | Objective Response Rate (ORR) | Study Track 2 | 25.0 Percent of Participants |
| Nivolumab + Ipilimumab | Objective Response Rate (ORR) | Study Track 1 | 0 Percent of Participants |
| Nivolumab + Ipilimumab | Objective Response Rate (ORR) | Study Track 3 | 5.6 Percent of Participants |
| Nivolumab + Ipilimumab | Objective Response Rate (ORR) | Study Track 4 | 20.0 Percent of Participants |
| Nivolumab + BMS986205 | Objective Response Rate (ORR) | Study Track 5 | 2.3 Percent of Participants |
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. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (\>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (\<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Time frame: From first dose to 24 weeks after first dose
Population: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 2 | NA Proportion of Participants |
| Nivolumab | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 1 | 0.302 Proportion of Participants |
| Nivolumab + Dasatinib | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 4 | NA Proportion of Participants |
| Nivolumab + Dasatinib | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 2 | NA Proportion of Participants |
| Nivolumab + Dasatinib | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 3 | 0.191 Proportion of Participants |
| Nivolumab + Dasatinib | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 1 | NA Proportion of Participants |
| Nivolumab + BMS986016 | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 2 | NA Proportion of Participants |
| Nivolumab + BMS986016 | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 3 | NA Proportion of Participants |
| Nivolumab + Ipilimumab | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 2 | 0.455 Proportion of Participants |
| Nivolumab + Ipilimumab | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 1 | NA Proportion of Participants |
| Nivolumab + Ipilimumab | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 3 | NA Proportion of Participants |
| Nivolumab + Ipilimumab | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 4 | 0.391 Proportion of Participants |
| Nivolumab + BMS986205 | Progression Free Survival Rate (PFSR) at 24 Weeks | Study Track 5 | 0.111 Proportion of Participants |
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
The following measurements will be considered laboratory abnormalities for hepatic tests: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper Limit of Normal
Time frame: From first dose to 100 days following last dose (approximately 9 months)
Population: All treated participants with available measurements. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. When measurements were available, these participants were analyzed under both groups they received treatment for.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 3XULN | 4 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN | 0 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN | 0 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 10XULN | 2 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 5XULN | 2 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 20XULN | 0 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 20XULN | 0 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 5XULN | 0 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 3XULN | 3 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN | 0 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 10XULN | 0 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN | 0 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 20XULN | 0 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 3XULN | 1 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 5XULN | 0 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 10XULN | 0 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN | 0 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 10XULN | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | TOTAL BILIRUBIN > 2XULN | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 5XULN | 3 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 3XULN | 5 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 20XULN | 1 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 10XULN | 2 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN | 2 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN | 2 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | TOTAL BILIRUBIN > 2XULN | 3 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 5XULN | 2 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 3XULN | 3 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | ALT OR AST > 20XULN | 1 Participants |
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
The following measurements will be considered laboratory abnormalities for thyroid tests: * TSH value \> ULN and * With baseline TSH value ≤ ULN * At least one T3/T4 test value \< LLN * Low TSH \< LLN and * With baseline TSH value ≥ LLN * At least one T3/T4 test value \> ULN TSH = thyroid stimulating hormone ULN=Upper Limit of Normal LLN=Lower Limit of Normal T3=Triiodothyronine T4=Thyroxine
Time frame: From first dose to 100 days following last dose (approximately 9 months)
Population: All treated participants with available measurements. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. When measurements were available, these participants were analyzed under both groups they received treatment for.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN | 9 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 6 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 4 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN | 5 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 5 Participants |
| Nivolumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 3 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN | 16 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 3 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN | 3 Participants |
| Nivolumab + Dasatinib | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 9 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN | 0 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 0 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN | 3 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 1 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 1 Participants |
| Nivolumab + BMS986016 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN | 20 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 17 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 8 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 5 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 16 Participants |
| Nivolumab + Ipilimumab | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN | 24 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 4 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 6 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 6 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH < LLN | 4 Participants |
| Nivolumab + BMS986205 | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | TSH > ULN | 9 Participants |
Percentage of Participants Experiencing Adverse Events (AEs)
This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame
Time frame: From first dose to 100 days following last dose
Population: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab | Percentage of Participants Experiencing Adverse Events (AEs) | 100.0 Percent of Participants |
| Nivolumab + Dasatinib | Percentage of Participants Experiencing Adverse Events (AEs) | 100.0 Percent of Participants |
| Nivolumab + BMS986016 | Percentage of Participants Experiencing Adverse Events (AEs) | 100.0 Percent of Participants |
| Nivolumab + Ipilimumab | Percentage of Participants Experiencing Adverse Events (AEs) | 98.9 Percent of Participants |
| Nivolumab + BMS986205 | Percentage of Participants Experiencing Adverse Events (AEs) | 100.0 Percent of Participants |
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame
Time frame: From first dose to 100 days following last dose
Population: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab | Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | 14.3 Percent of Participants |
| Nivolumab + Dasatinib | Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | 23.6 Percent of Participants |
| Nivolumab + BMS986016 | Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | 5.6 Percent of Participants |
| Nivolumab + Ipilimumab | Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | 11.8 Percent of Participants |
| Nivolumab + BMS986205 | Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | 14.0 Percent of Participants |
Percentage of Participants Experiencing Death
This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame
Time frame: From first dose to up to 45 months following first dose
Population: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab | Percentage of Participants Experiencing Death | 57.1 Percent of Participants |
| Nivolumab + Dasatinib | Percentage of Participants Experiencing Death | 55.7 Percent of Participants |
| Nivolumab + BMS986016 | Percentage of Participants Experiencing Death | 66.7 Percent of Participants |
| Nivolumab + Ipilimumab | Percentage of Participants Experiencing Death | 46.2 Percent of Participants |
| Nivolumab + BMS986205 | Percentage of Participants Experiencing Death | 62.8 Percent of Participants |
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame
Time frame: From first dose to 100 days following last dose
Population: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab | Percentage of Participants Experiencing Serious Adverse Events (SAEs) | 57.1 Percent of Participants |
| Nivolumab + Dasatinib | Percentage of Participants Experiencing Serious Adverse Events (SAEs) | 53.8 Percent of Participants |
| Nivolumab + BMS986016 | Percentage of Participants Experiencing Serious Adverse Events (SAEs) | 61.1 Percent of Participants |
| Nivolumab + Ipilimumab | Percentage of Participants Experiencing Serious Adverse Events (SAEs) | 58.1 Percent of Participants |
| Nivolumab + BMS986205 | Percentage of Participants Experiencing Serious Adverse Events (SAEs) | 60.5 Percent of Participants |