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An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer

A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02750514
Acronym
FRACTION-Lung
Enrollment
295
Registered
2016-04-25
Start date
2016-05-09
Completion date
2020-01-29
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

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

BIOLOGICALNivolumab

Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.

DRUGDasatinib
BIOLOGICALRelatlimab
BIOLOGICALIpilimumab

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

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

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

MeasureTime frameDescription
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 WeeksFrom first dose to 24 weeks after first doseThe 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

MeasureTime frameDescription
Percentage of Participants Experiencing DeathFrom first dose to up to 45 months following first doseThis 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 doseThis 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 TestsFrom 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 TestsFrom 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 doseThis 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 DiscontinuationFrom first dose to 100 days following last doseThis 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

ArmCount
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
Total295

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Track 1Adverse event unrelated to study drug10000
Track 1Disease progression201010
Track 1Other reasons10000
Track 1Participant request to discontinue10000
Track 1Study drug toxicity41010
Track 2Adverse event unrelated to study drug10000
Track 2Disease progression45250
Track 2Participant withdrew consent01000
Track 2Study drug toxicity12020
Track 3Adverse event unrelated to study drug01110
Track 3Disease progression02413140
Track 3Other reasons03000
Track 3Participant request to discontinue02000
Track 3Participant withdrew consent03100
Track 3Study drug toxicity03010
Track 4Adverse event unrelated to study drug05000
Track 4Death00010
Track 4Disease progression0330320
Track 4Other reasons05030
Track 4Participant request to discontinue01010
Track 4Participant withdrew consent01000
Track 4Study drug toxicity06050
Track 5Adverse event unrelated to study drug00002
Track 5Disease progression000034
Track 5Other reasons00002
Track 5Participant request to discontinue00003
Track 5Study drug toxicity00002

Baseline characteristics

CharacteristicNivolumabNivolumab + DasatinibNivolumab + BMS986016Nivolumab + IpilimumabNivolumab + BMS986205Total
Age, Continuous64.5 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 Participants2 Participants0 Participants5 Participants1 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants65 Participants17 Participants58 Participants27 Participants192 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
23 Participants37 Participants0 Participants25 Participants9 Participants94 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants7 Participants2 Participants2 Participants3 Participants16 Participants
Race (NIH/OMB)
Black or African American
0 Participants6 Participants1 Participants6 Participants6 Participants19 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants6 Participants0 Participants2 Participants2 Participants15 Participants
Race (NIH/OMB)
White
42 Participants85 Participants14 Participants78 Participants26 Participants245 Participants
Sex: Female, Male
Female
21 Participants34 Participants8 Participants38 Participants21 Participants122 Participants
Sex: Female, Male
Male
28 Participants70 Participants9 Participants50 Participants16 Participants173 Participants

Adverse events

Event typeEG000
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 / 402 / 41 / 36 / 94 / 82 / 26 / 1220 / 4110 / 169 / 1833 / 5327 / 6027 / 43
other
Total, other adverse events
38 / 404 / 43 / 39 / 97 / 82 / 212 / 1238 / 4116 / 1617 / 1850 / 5359 / 6041 / 43
serious
Total, serious adverse events
24 / 402 / 40 / 34 / 95 / 82 / 25 / 1217 / 419 / 1610 / 1833 / 5339 / 6026 / 43

Outcome results

Primary

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).

ArmMeasureGroupValue (MEDIAN)
NivolumabDuration of Response (DOR)Study Track 112.81 Months
Nivolumab + DasatinibDuration of Response (DOR)Study Track 4NA Months
Nivolumab + DasatinibDuration of Response (DOR)Study Track 18.57 Months
Nivolumab + DasatinibDuration of Response (DOR)Study Track 3NA Months
Nivolumab + IpilimumabDuration of Response (DOR)Study Track 3NA Months
Nivolumab + IpilimumabDuration of Response (DOR)Study Track 2NA Months
Nivolumab + IpilimumabDuration of Response (DOR)Study Track 412.65 Months
Nivolumab + BMS986205Duration of Response (DOR)Study Track 53.75 Months
Primary

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.

ArmMeasureGroupValue (NUMBER)
NivolumabObjective Response Rate (ORR)Study Track 20 Percent of Participants
NivolumabObjective Response Rate (ORR)Study Track 117.5 Percent of Participants
Nivolumab + DasatinibObjective Response Rate (ORR)Study Track 41.9 Percent of Participants
Nivolumab + DasatinibObjective Response Rate (ORR)Study Track 20 Percent of Participants
Nivolumab + DasatinibObjective Response Rate (ORR)Study Track 32.4 Percent of Participants
Nivolumab + DasatinibObjective Response Rate (ORR)Study Track 125.0 Percent of Participants
Nivolumab + BMS986016Objective Response Rate (ORR)Study Track 20 Percent of Participants
Nivolumab + BMS986016Objective Response Rate (ORR)Study Track 30 Percent of Participants
Nivolumab + IpilimumabObjective Response Rate (ORR)Study Track 225.0 Percent of Participants
Nivolumab + IpilimumabObjective Response Rate (ORR)Study Track 10 Percent of Participants
Nivolumab + IpilimumabObjective Response Rate (ORR)Study Track 35.6 Percent of Participants
Nivolumab + IpilimumabObjective Response Rate (ORR)Study Track 420.0 Percent of Participants
Nivolumab + BMS986205Objective Response Rate (ORR)Study Track 52.3 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. 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.

ArmMeasureGroupValue (NUMBER)
NivolumabProgression Free Survival Rate (PFSR) at 24 WeeksStudy Track 2NA Proportion of Participants
NivolumabProgression Free Survival Rate (PFSR) at 24 WeeksStudy Track 10.302 Proportion of Participants
Nivolumab + DasatinibProgression Free Survival Rate (PFSR) at 24 WeeksStudy Track 4NA Proportion of Participants
Nivolumab + DasatinibProgression Free Survival Rate (PFSR) at 24 WeeksStudy Track 2NA Proportion of Participants
Nivolumab + DasatinibProgression Free Survival Rate (PFSR) at 24 WeeksStudy Track 30.191 Proportion of Participants
Nivolumab + DasatinibProgression Free Survival Rate (PFSR) at 24 WeeksStudy Track 1NA Proportion of Participants
Nivolumab + BMS986016Progression Free Survival Rate (PFSR) at 24 WeeksStudy Track 2NA Proportion of Participants
Nivolumab + BMS986016Progression Free Survival Rate (PFSR) at 24 WeeksStudy Track 3NA Proportion of Participants
Nivolumab + IpilimumabProgression Free Survival Rate (PFSR) at 24 WeeksStudy Track 20.455 Proportion of Participants
Nivolumab + IpilimumabProgression Free Survival Rate (PFSR) at 24 WeeksStudy Track 1NA Proportion of Participants
Nivolumab + IpilimumabProgression Free Survival Rate (PFSR) at 24 WeeksStudy Track 3NA Proportion of Participants
Nivolumab + IpilimumabProgression Free Survival Rate (PFSR) at 24 WeeksStudy Track 40.391 Proportion of Participants
Nivolumab + BMS986205Progression Free Survival Rate (PFSR) at 24 WeeksStudy Track 50.111 Proportion of Participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 3XULN4 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsConcurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN0 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsConcurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN0 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 10XULN2 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 5XULN2 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 20XULN0 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsTOTAL BILIRUBIN > 2XULN1 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsTOTAL BILIRUBIN > 2XULN0 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 20XULN0 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 5XULN0 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 3XULN3 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsConcurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN0 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 10XULN0 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsConcurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN0 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 20XULN0 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 3XULN1 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 5XULN0 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 10XULN0 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsTOTAL BILIRUBIN > 2XULN0 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsConcurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN0 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsConcurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN0 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 10XULN1 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsTOTAL BILIRUBIN > 2XULN2 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 5XULN3 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsConcurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN2 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsConcurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN2 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 3XULN5 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 20XULN1 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 10XULN2 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsConcurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN2 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsConcurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN2 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsTOTAL BILIRUBIN > 2XULN3 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 5XULN2 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 3XULN3 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Hepatic TestsALT OR AST > 20XULN1 Participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN9 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN WITH TSH <= ULN AT BASELINE6 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN4 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN5 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN WITH TSH >= LLN AT BASELINE5 Participants
NivolumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN3 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN WITH TSH >= LLN AT BASELINE1 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN1 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN16 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN3 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN3 Participants
Nivolumab + DasatinibNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN WITH TSH <= ULN AT BASELINE9 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN0 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN WITH TSH >= LLN AT BASELINE0 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN3 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN1 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN WITH TSH <= ULN AT BASELINE1 Participants
Nivolumab + BMS986016Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN0 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN20 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN WITH TSH <= ULN AT BASELINE17 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN8 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN5 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN WITH TSH >= LLN AT BASELINE16 Participants
Nivolumab + IpilimumabNumber of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN24 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN WITH TSH >= LLN AT BASELINE4 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN6 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN WITH TSH <= ULN AT BASELINE6 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN0 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH < LLN4 Participants
Nivolumab + BMS986205Number of Participants Experiencing Laboratory Abnormalities in Thyroid TestsTSH > ULN9 Participants
Secondary

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.

ArmMeasureValue (NUMBER)
NivolumabPercentage of Participants Experiencing Adverse Events (AEs)100.0 Percent of Participants
Nivolumab + DasatinibPercentage of Participants Experiencing Adverse Events (AEs)100.0 Percent of Participants
Nivolumab + BMS986016Percentage of Participants Experiencing Adverse Events (AEs)100.0 Percent of Participants
Nivolumab + IpilimumabPercentage of Participants Experiencing Adverse Events (AEs)98.9 Percent of Participants
Nivolumab + BMS986205Percentage of Participants Experiencing Adverse Events (AEs)100.0 Percent of Participants
Secondary

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.

ArmMeasureValue (NUMBER)
NivolumabPercentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation14.3 Percent of Participants
Nivolumab + DasatinibPercentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation23.6 Percent of Participants
Nivolumab + BMS986016Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation5.6 Percent of Participants
Nivolumab + IpilimumabPercentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation11.8 Percent of Participants
Nivolumab + BMS986205Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation14.0 Percent of Participants
Secondary

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.

ArmMeasureValue (NUMBER)
NivolumabPercentage of Participants Experiencing Death57.1 Percent of Participants
Nivolumab + DasatinibPercentage of Participants Experiencing Death55.7 Percent of Participants
Nivolumab + BMS986016Percentage of Participants Experiencing Death66.7 Percent of Participants
Nivolumab + IpilimumabPercentage of Participants Experiencing Death46.2 Percent of Participants
Nivolumab + BMS986205Percentage of Participants Experiencing Death62.8 Percent of Participants
Secondary

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.

ArmMeasureValue (NUMBER)
NivolumabPercentage of Participants Experiencing Serious Adverse Events (SAEs)57.1 Percent of Participants
Nivolumab + DasatinibPercentage of Participants Experiencing Serious Adverse Events (SAEs)53.8 Percent of Participants
Nivolumab + BMS986016Percentage of Participants Experiencing Serious Adverse Events (SAEs)61.1 Percent of Participants
Nivolumab + IpilimumabPercentage of Participants Experiencing Serious Adverse Events (SAEs)58.1 Percent of Participants
Nivolumab + BMS986205Percentage of Participants Experiencing Serious Adverse Events (SAEs)60.5 Percent of Participants

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026