CompletedNCT03369223Updated Nov 18, 2025Results posted

A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

A Phase 1/2 interventional study of BMS-986249 and Nivolumab in Advanced Cancer, sponsored by Bristol-Myers Squibb. Completed at 45 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 356
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Conditions studied

Advanced Cancer

Keywords

Antibodies
Antineoplastic Agents
Immunologic Factors
Nivolumab
Antibodies, Monoclonal
Physiological Effects of Drugs

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists
Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
Willing and able to comply with all study procedures

Exclusion criteria

Exclusion Criteria:

Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
Other active malignancy requiring concurrent intervention
Prior organ allograft
Active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 356 participants (actual)

Study arms

Experimental
Part 1A: BMS-986249
Biological: BMS-986249
Experimental
Part 1B: BMS-986249 + nivolumab (nivo)
Biological: BMS-986249 · Biological: Nivolumab
Experimental
Part 2A Arm C: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
Biological: BMS-986249 · Biological: Nivolumab
Experimental
Part 2A Arm D: ipilimumab + nivo then nivo
Previously untreated unresectable stage III-IV melanoma
Biological: Nivolumab · Biological: Ipilimumab
Experimental
Part 2A Arm F: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
Biological: BMS-986249 · Biological: Nivolumab
Experimental
Part 2B Cohort 1: BMS-986249 + nivo
Advanced or intermediate hepatocellular carcinoma (HCC)
Biological: BMS-986249 · Biological: Nivolumab
Experimental
Part 2B Cohort 2: BMS-986249 + nivo
Metastatic castration-resistant prostate cancer (CRPC)
Biological: BMS-986249 · Biological: Nivolumab
Experimental
Part 2B Cohort 3: BMS-986249 + nivo
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
Biological: BMS-986249 · Biological: Nivolumab
Experimental
Part 2A Arm A: BMS-986249 + nivo then nivo
* Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm
Biological: BMS-986249 · Biological: Nivolumab
Experimental
Part 2A Arm B: BMS-986249 + nivo
* Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm
Biological: BMS-986249 · Biological: Nivolumab
Experimental
Part 2A Arm E: Nivo
* Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm
Biological: Nivolumab

Interventions

BiologicalBMS-986249
Specified dose on specified days
BiologicalNivolumab
Specified dose on specified days
Also known as: Opdivo, BMS-936558
BiologicalIpilimumab
Specified dose on specified days
Also known as: Yervoy, BMS-734016

What researchers measure

Primary outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B
Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Serious Adverse Events (SAEs): Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.
Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)
Number of Participants With Adverse Events (AEs) Meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B
Dose-limiting toxicities (DLTs) were defined by the incidence, intensity, and duration of adverse events (AEs) possibly related to study treatment during the 5-week (35-day) DLT evaluation period for both BMS-986249 monotherapy and combination therapy. Participants who received at least 2 doses and completed or discontinued due to a DLT within this period were considered DLT-evaluable. Those who withdrew or received less than 2 doses for reasons other than a DLT were not DLT-evaluable and could be replaced. Any drug-related AE meeting DLT criteria resulted in discontinuation of study treatment. DLTs guided dose escalation and helped define the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
Time frame: From first dose until 5 weeks after first dose of study medicine (up to approximately 5 weeks)
Number of Participants Who Died - Part 1 A and 1 B
Number of Participants who Died
Time frame: From enrollment until the date of death from any cause (up to approximately 83 months)
Number of Participants With Shifts From Baseline in Laboratory Tests Results - Part 1 A and 1 B
Number of Participants with Shifts from Baseline in Laboratory Tests
Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)
Number of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 Weeks - Part 2 A Arms C, D and F, and Part 2 B
Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention needed. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention required. Grade 5: Death related to the adverse event.
Time frame: From first dose until 24 weeks after first dose (up to approximately 24 weeks)
Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F
Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to \<10mm. Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From randomization until progression or death from any cause (up to approximately 83 months)

Secondary outcomes

Time to Deterioration in Part 2A (Arm C, D and F)
TTD in Global Health Status/QoL and Physical Functioning will be defined as the time from randomization until a clinically meaningful decline (i.e., reduction ≥10 points) from baseline in EORTC QLQ-C30 global health/quality of life subscale score and Physical Functioning Scale score.
Time frame: Approximately up to 6 months
Safety Related Events in Part 2A (Arm C, D and F) and 2B
Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Serious Adverse Events (SAEs): Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.
Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)
BOR of PSA and PCWG3 Response Rate in Part 2B Cohort 2
Best Overall Response (BOR) is defined as the best response recorded from the start of randomization or first dosing date until the date of objectively documented PD based on RECIST v1.1 criteria or PCWG3 (for prostate cancer), or the date of ubsequent therapy (including tumordirected radiotherapy and tumor-directed surgery which are not for palliative purpose), whichever occurs first.
Time frame: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
Progression Free Survival
Defined as the time between the date of randomization (Part 2A), or first dosing for Part 1 and supplemental analysis in Part 2A, and the date of first documented tumor progression, based on investigator assessments (per RECIST v1.1 criteria or PCWG3), or death due to any cause, whichever occurs first.
Time frame: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
Duration of Response
Defined as the time between the date of first documented response (CR or PR) to the date of the first documented tumor progression, as determined by RECIST v1.1 or PCWG3 criteria, or death due to any cause, whichever occurs first. Subjects who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjects who neither progress nor die, DOR will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
Time frame: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
Time to Response
Defined as the time from first dosing (Part 1)/randomization (Part 2A) to the date of the first confirmed documented response (CR or PR). TTR will be evaluated for responders (confirmed CR or PR) only.
Time frame: From first dose to first objective response (Approximately up to 3 Months)
Objective Response Rate (ORR) as Assessed by Investigator - Part 1 A, 1B, 2A (Arms C,D,F) and 2B
Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Working Group (PCWG) 3. For both RECIST v1.1 and PCWG3: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to \<10mm. Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
Cmax and Ctau of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B
Cmax: The highest concentration of BMS-986249 in the blood after dosing. Ctau: The concentration of BMS-986249 in the blood at the end of a dosing interval, just before the next dose
Time frame: On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)
AUC(0-T) and AUC(TAU) of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B
AUC(0-T): The total amount of BMS-986249 in the blood from the time it is given until a specific time point. AUC(TAU): The total amount of BMS-986249 in the blood over one dosing interval
Time frame: On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)
Accumulation Index for Cmax (AI_Cmax) and Accumulation Index for AUC (AI_AUC) of BMS-986249 - Part 1 A and B, Part 2 A Arms C, D and F, Part 2 B
AI\_Cmax: How much the highest concentration of BMS-986249 increases after multiple doses compared to a single dose. AI\_AUC: How much the total exposure to BMS-986249 increases after multiple doses compared to a single dose.
Time frame: On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)
Number of Participants With Shifts From Baseline in Laboratory Test Results - Part 2A (Arms C and F) and 2B
Number of Participants with Shifts from Baseline in Laboratory Tests
Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

Results

Posted Nov 18, 2025

Participant flow

Participant flow — Overall Study
Milestone	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm A: BMS-986249 240 mg Q3W + Nivolumab 360 mg Q3W	Part 2A: Melanoma Arm B: BMS-986249 800 mg + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm E: Nivolumab 480 mg Q4W Monotherapy	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W
Started	6	11	10	1	11	12	11	9	13	9	10	3	3	58	59	3	36	5	41	45
Treated	6	11	10	1	11	12	11	9	13	9	10	3	3	57	58	3	36	5	41	45
Completed	0	0	0	0	0	0	0	0	0	1	0	0	0	6	7	1	2	0	1	3
Not completed	6	11	10	1	11	12	11	9	13	8	10	3	3	52	52	2	34	5	40	42
Withdrew: Lost to follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1
Withdrew: Participant no longer meets study criteria	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	2	0	0	0
Withdrew: Other reasons	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	1	0	0	2
Withdrew: Death	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0
Withdrew: Adverse event unrelated to study drug	0	0	0	0	0	0	1	0	0	1	0	0	0	4	2	0	2	1	3	2
Withdrew: Disease progression	6	8	5	1	9	9	4	6	10	7	4	1	1	25	22	2	10	1	18	28
Withdrew: Study drug toxicity	0	1	4	0	1	2	4	2	2	0	6	1	2	19	19	0	18	3	11	7
Withdrew: Participant request to discontinue study treatment	0	1	0	0	1	1	1	0	0	0	0	0	0	1	1	0	0	0	1	0
Withdrew: Participant withdrew consent	0	1	1	0	0	0	1	1	1	0	0	1	0	0	3	0	1	0	4	2
Withdrew: Randomized but not treated	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0

Outcome measures

PrimaryNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B

Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Serious Adverse Events (SAEs): Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.

Time frame:: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B
Participants	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination
Adverse events (AEs)	6	11	10	1	11	12	11	9	13	9	10
Serious adverse events (SAEs)	4	8	8	1	7	8	7	7	10	7	8
Adverse events (AEs) leading to discontinuation	0	2	4	0	2	3	5	4	2	3	5

PrimaryNumber of Participants With Adverse Events (AEs) Meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B

Dose-limiting toxicities (DLTs) were defined by the incidence, intensity, and duration of adverse events (AEs) possibly related to study treatment during the 5-week (35-day) DLT evaluation period for both BMS-986249 monotherapy and combination therapy. Participants who received at least 2 doses and completed or discontinued due to a DLT within this period were considered DLT-evaluable. Those who withdrew or received less than 2 doses for reasons other than a DLT were not DLT-evaluable and could be replaced. Any drug-related AE meeting DLT criteria resulted in discontinuation of study treatment. DLTs guided dose escalation and helped define the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

Time frame:: From first dose until 5 weeks after first dose of study medicine (up to approximately 5 weeks)
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events (AEs) Meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B
Participants	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination
Number of Participants With Adverse Events (AEs) Meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B	0	0	1	0	1	0	1	0	0	0	3

PrimaryNumber of Participants Who Died - Part 1 A and 1 B

Number of Participants who Died

Time frame:: From enrollment until the date of death from any cause (up to approximately 83 months)
Reported as:: Count of participants · Participants

Number of Participants Who Died - Part 1 A and 1 B
Participants	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination
Number of Participants Who Died - Part 1 A and 1 B	4	10	7	1	6	11	8	7	8	4	9

PrimaryNumber of Participants With Shifts From Baseline in Laboratory Tests Results - Part 1 A and 1 B

Number of Participants with Shifts from Baseline in Laboratory Tests

Time frame:: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)
Reported as:: Count of participants · Participants

Number of Participants With Shifts From Baseline in Laboratory Tests Results - Part 1 A and 1 B
Participants	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination
HEMOGLOBIN	3	4	7	1	4	10	9	6	7	4	7
PLATELET COUNT	1	1	2	0	0	0	3	0	2	1	3
LEUKOCYTES, LOCAL LAB	1	0	1	0	2	3	4	0	2	1	3
ABSOLUTE NEUTROPHIL COUNT DRV	0	0	0	0	2	0	4	0	1	2	2
LYMPHOCYTES (ABSOLUTE)	2	1	3	—	0	0	1	0	2	2	0
LYMPHOCYTES (ABSOLUTE), LOCAL LAB	2	7	6	0	3	6	5	5	1	6	4
CREATININE, LOCAL LAB	0	4	1	0	1	1	1	1	3	2	5
ALKALINE PHOSPHATASE (ALP) LOCAL LAB	1	7	1	1	3	5	4	6	5	2	6
ALANINE AMINOTRANSFERASE (ALT), LOCAL LAB	2	4	2	0	2	4	4	4	5	3	4
ASPARTATE AMINOTRANSFERASE (AST), LOCAL LAB	2	7	3	1	3	4	6	4	5	3	5
BILIRUBIN, TOTAL, LOCAL LAB	2	1	1	1	1	1	5	2	4	3	2

PrimaryNumber of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 Weeks - Part 2 A Arms C, D and F, and Part 2 B

Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention needed. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention required. Grade 5: Death related to the adverse event.

Time frame:: From first dose until 24 weeks after first dose (up to approximately 24 weeks)
Reported as:: Count of participants · Participants

Number of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 Weeks - Part 2 A Arms C, D and F, and Part 2 B
Participants	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W
Number of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 Weeks - Part 2 A Arms C, D and F, and Part 2 B	24	18	14	4	13	11

PrimaryObjective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F

Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to \<10mm. Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Time frame:: From randomization until progression or death from any cause (up to approximately 83 months)
Reported as:: Number · Percentage of participants

Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F
Percentage of participants	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W
Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F	36.2 (24.0 to 49.9)	52.8 (35.5 to 69.6)

SecondaryTime to Deterioration in Part 2A (Arm C, D and F)

TTD in Global Health Status/QoL and Physical Functioning will be defined as the time from randomization until a clinically meaningful decline (i.e., reduction ≥10 points) from baseline in EORTC QLQ-C30 global health/quality of life subscale score and Physical Functioning Scale score.

Time frame:: Approximately up to 6 months
Reported as:: Median · Months

Time to Deterioration in Part 2A (Arm C, D and F)
Months	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W
Time to Deterioration in Part 2A (Arm C, D and F)	3.52 (1.87 to 5.29)	4.37 (1.51 to 5.78)	2.79 (1.22 to 5.65)

SecondarySafety Related Events in Part 2A (Arm C, D and F) and 2B

Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Serious Adverse Events (SAEs): Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.

Time frame:: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)
Reported as:: Number · Template

Safety Related Events in Part 2A (Arm C, D and F) and 2B
Template	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W
Adverse Events	57	57	35	5	40	45
Serious Adverse Events	41	28	20	5	29	25
AEs leading to discontinuation	24	25	20	4	13	13
Deaths	27	24	10	4	26	28

SecondaryBOR of PSA and PCWG3 Response Rate in Part 2B Cohort 2

Best Overall Response (BOR) is defined as the best response recorded from the start of randomization or first dosing date until the date of objectively documented PD based on RECIST v1.1 criteria or PCWG3 (for prostate cancer), or the date of ubsequent therapy (including tumordirected radiotherapy and tumor-directed surgery which are not for palliative purpose), whichever occurs first.

Time frame:: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
Reported as:: Number · Percentage of participants

BOR of PSA and PCWG3 Response Rate in Part 2B Cohort 2
Percentage of participants	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W
PSA Response Rate	14.6 (5.6 to 29.2)
PCWG3 Response Rate	9.8 (2.7 to 23.1)

SecondaryProgression Free Survival

Defined as the time between the date of randomization (Part 2A), or first dosing for Part 1 and supplemental analysis in Part 2A, and the date of first documented tumor progression, based on investigator assessments (per RECIST v1.1 criteria or PCWG3), or death due to any cause, whichever occurs first.

Time frame:: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
Reported as:: Median · Months

Progression Free Survival
Months	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W
Progression Free Survival	1.74 (1.41 to NA)	1.77 (1.15 to 1.84)	1.69 (0.53 to 3.25)	3.55 (NA to NA)	1.68 (1.05 to NA)	2.33 (1.68 to 3.32)	1.71 (0.85 to 14.23)	3.32 (1.22 to 4.40)	1.92 (0.59 to 7.13)	1.91 (1.02 to NA)	4.35 (0.92 to 12.45)	6.51 (4.90 to 12.52)	4.73 (2.89 to 9.76)	10.38 (6.74 to NA)	2.99 (1.77 to NA)	5.62 (3.68 to 8.28)	3.35 (1.84 to 5.36)

SecondaryDuration of Response

Defined as the time between the date of first documented response (CR or PR) to the date of the first documented tumor progression, as determined by RECIST v1.1 or PCWG3 criteria, or death due to any cause, whichever occurs first. Subjects who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjects who neither progress nor die, DOR will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.

Time frame:: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
Reported as:: Median · Months

Duration of Response
Months	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W
Duration of Response	—	—	—	—	—	—	NA (12.48 to NA)	—	15.80 (1.68 to NA)	NA (1.74 to NA)	NA (8.97 to NA)	26.84 (7.85 to NA)	NA (7.2 to NA)	NA (6.47 to NA)	—	NA (NA to NA)	21.49 (3.68 to NA)

SecondaryTime to Response

Defined as the time from first dosing (Part 1)/randomization (Part 2A) to the date of the first confirmed documented response (CR or PR). TTR will be evaluated for responders (confirmed CR or PR) only.

Time frame:: From first dose to first objective response (Approximately up to 3 Months)
Reported as:: Median · Months

Time to Response
Months	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W
Time to Response	—	—	—	—	—	—	2.76 (1.8 to 3.7)	—	1.74 (1.7 to 3.9)	3.48 (3.48 to 5.4)	4.01 (3.5 to 4.3)	2.86 (2.1 to 8.6)	2.83 (2.0 to 26.4)	2.83 (2.66 to 4.44)	—	2.84 (1.7 to 3.9)	1.87 (1.74 to 2.76)

SecondaryObjective Response Rate (ORR) as Assessed by Investigator - Part 1 A, 1B, 2A (Arms C,D,F) and 2B

Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Working Group (PCWG) 3. For both RECIST v1.1 and PCWG3: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to \<10mm. Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Time frame:: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
Reported as:: Number · Percentage of participants

Objective Response Rate (ORR) as Assessed by Investigator - Part 1 A, 1B, 2A (Arms C,D,F) and 2B
Percentage of participants	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W
Objective Response Rate (ORR) as Assessed by Investigator - Part 1 A, 1B, 2A (Arms C,D,F) and 2B	0 (0.0 to 45.9)	0 (0.0 to 28.5)	0 (0.0 to 30.8)	0 (0.0 to 97.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	18.2 (2.3 to 51.8)	0 (0.0 to 33.6)	23.1 (5.0 to 53.8)	33.3 (7.5 to 70.1)	30.0 (6.7 to 65.2)	31.0 (19.5 to 44.5)	27.1 (16.4 to 40.3)	50.0 (32.9 to 67.1)

SecondaryCmax and Ctau of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B

Cmax: The highest concentration of BMS-986249 in the blood after dosing. Ctau: The concentration of BMS-986249 in the blood at the end of a dosing interval, just before the next dose

Time frame:: On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)
Reported as:: Geometric mean · ng/mL

Cmax and Ctau of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B
ng/mL	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W
Cmax Cycle 1 Day 1	398 ± 24	1451 ± 39	3569 ± 27	4965 ± NA	2735 ± 31	454 ± 27	1322 ± 40	1729 ± 39	1397 ± 27	2105 ± 26	3146 ± 38	2274 ± 49	1114 ± 34	1752 ± 40	2050 ± 27	2404 ± 41
Cmax C3D1	—	—	—	—	2919 ± 48	—	—	—	1894 ± 33	1817 ± 32	2771 ± 28	—	—	—	—	—
Cmax Cycle 4 Day 1	432 ± 55	1425 ± 14	5299 ± NA	3910 ± NA	—	570 ± 9	1706 ± 21	1436 ± NA	—	—	—	—	930 ± 38	—	—	—
Cmax C5D1	—	—	—	—	—	—	—	—	—	—	—	2022 ± 50	—	—	—	—
Ctau Cycle 1 Day 1	7.69 ± 4151	174 ± 71	344 ± 418	385 ± NA	52.6 ± 181	45.8 ± 322	143 ± 51	159 ± 58	20.2 ± 206	—	58.7 ± 190	57.9 ± 300	153 ± 34	82.3 ± 61	79.3 ± 98	66.2 ± 153
Ctau C3D1	—	—	—	—	149 ± 24	—	—	—	94.4 ± 7	—	152 ± 45	—	—	—	—	—
Ctau Cycle 4 Day 1	51.6 ± 255	1425 ± 14	—	236 ± NA	—	170 ± 11	115 ± 310	107 ± NA	—	—	—	—	151 ± 53	—	—	—
CTau C5D1	—	—	—	—	—	—	—	—	—	—	—	100 ± 83	—	—	—	—

SecondaryAUC(0-T) and AUC(TAU) of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B

AUC(0-T): The total amount of BMS-986249 in the blood from the time it is given until a specific time point. AUC(TAU): The total amount of BMS-986249 in the blood over one dosing interval

Time frame:: On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)
Reported as:: Geometric mean · ng*h/mL

AUC(0-T) and AUC(TAU) of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B
ng*h/mL	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W
AUC (0-T) Cycle 1 Day 1	77826 ± 48	294432 ± 39	745654 ± 40	991294 ± NA	671019 ± 48	96709 ± 49	292555 ± 32	378115 ± 31	325275 ± 35	521156 ± 36	688556 ± 29	612513 ± 44	255384 ± 23	653770 ± 7	638435 ± 24	696815 ± 34
AUC (Tau) Cycle 1 Day 1	67094 ± 53	288621 ± 37	629431 ± 55	999415 ± NA	484593 ± 74	88780 ± 61	282516 ± 32	326037 ± 40	259533 ± 35	458972 ± 41	532540 ± 43	464205 ± 81	231346 ± 48	407104 ± 56	438370 ± 70	554691 ± 52
AUC (0-T) Cycle 4 Day 1	432 ± 55	284353 ± 45	—	687899 ± NA	—	181278 ± 9	338096 ± 49	255093 ± NA	—	—	—	—	260319 ± 35	—	—	—
AUC (Tau) Cycle 4 Day 1	51.6 ± 255	147763 ± 25	114154 ± NA	536764 ± NA	—	139951 ± 71	223315 ± 64	255093 ± NA	—	—	—	—	229430 ± 37	—	—	—
AUC (0-T) C3D1	—	—	—	—	1121470 ± 53	—	—	—	611831 ± 19	780896 ± 45	972214 ± 28	—	—	—	—	—
AUC (Tau) C3D1	—	—	—	—	1121470 ± 53	—	—	—	611831 ± 19	780896 ± 45	937806 ± 25	—	—	—	—	—
AUC (0-T) C5D1	—	—	—	—	—	—	—	—	—	—	—	675816 ± 33	—	—	—	—
AUC (Tau) C5D1	—	—	—	—	—	—	—	—	—	—	—	564180 ± 52	—	—	—	—

SecondaryAccumulation Index for Cmax (AI_Cmax) and Accumulation Index for AUC (AI_AUC) of BMS-986249 - Part 1 A and B, Part 2 A Arms C, D and F, Part 2 B

AI\_Cmax: How much the highest concentration of BMS-986249 increases after multiple doses compared to a single dose. AI\_AUC: How much the total exposure to BMS-986249 increases after multiple doses compared to a single dose.

Time frame:: On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)
Reported as:: Geometric mean · ratio

Accumulation Index for Cmax (AI_Cmax) and Accumulation Index for AUC (AI_AUC) of BMS-986249 - Part 1 A and B, Part 2 A Arms C, D and F, Part 2 B
ratio	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W
AI (AUC) Cycle 4 Day 1	1.29 ± 11	1.07 ± 29	—	0.694 ± NA	—	1.54 ± 1	1.23 ± 16	1.29 ± NA	—	—	—	—	0.971 ± 24	—	—	—
AI Cmax Cycle 4 Day 1	1.02 ± 14	324 ± NA	1.32 ± NA	0.788 ± NA	—	1.28 ± 10	1.25 ± 17	1.62 ± NA	—	—	—	—	0.899 ± 64	—	—	—
AI (AUC) C3D1	—	—	—	—	1.35 ± 7	—	—	—	1.82 ± 43	1.3 ± 17	1.46 ± 11	—	—	—	—	—
AI Cmax C3D1	—	—	—	—	1.17 ± 3	—	—	—	1.58 ± 85	0.918 ± 16	0.978 ± 14	—	—	—	—	—
AI (AUC) C5D1	—	—	—	—	—	—	—	—	—	—	—	1.13 ± 18	—	—	—	—
AI Cmax C5D1	—	—	—	—	—	—	—	—	—	—	—	1.11 ± 53	—	—	—	—

SecondaryNumber of Participants With Shifts From Baseline in Laboratory Test Results - Part 2A (Arms C and F) and 2B

Number of Participants with Shifts from Baseline in Laboratory Tests

Time frame:: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)
Reported as:: Count of participants · Participants

Number of Participants With Shifts From Baseline in Laboratory Test Results - Part 2A (Arms C and F) and 2B
Participants	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q6W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm F: BMS-986249 1200 mg Q6W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC):	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q6W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q6W + Nivolumab 480 mg Q4W
HEMOGLOBIN	42	43	25	3	32	33
PLATELET COUNT	13	10	7	2	15	12
LEUKOCYTES, LOCAL LAB	12	10	6	0	9	14
ABSOLUTE NEUTROPHIL COUNT DRV	7	8	6	0	9	10
LYMPHOCYTES (ABSOLUTE)	9	19	10	0	11	11
LYMPHOCYTES (ABSOLUTE), LOCAL LAB	23	12	10	2	9	17
CREATININE, LOCAL LAB	20	17	10	3	14	5
ALKALINE PHOSPHATASE (ALP) LOCAL LAB	24	30	19	3	17	25
ALANINE AMINOTRANSFERASE (ALT), LOCAL LAB	38	40	23	4	18	27
ASPARTATE AMINOTRANSFERASE (AST), LOCAL LAB	27	40	22	3	19	31
BILIRUBIN, TOTAL, LOCAL LAB	12	18	7	3	12	5

Adverse events

Collected over Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 38 weeks All-Cause mortality (From randomization to end of study): Approximately 83 Months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1A: BMS-986249 240mg Monotherapy	4/6 (66.7%)	4/6 (66.7%)	6/6 (100%)
Part 1A: BMS-986249 800mg Monotherapy	10/11 (90.9%)	8/11 (72.7%)	11/11 (100%)
Part 1A: BMS-986249 1600mg Q4W Monotherapy	7/10 (70%)	8/10 (80%)	9/10 (90%)
Part 1A: BMS-986249 2400mg Monotherapy	1/1 (100%)	1/1 (100%)	1/1 (100%)
Part 1A: BMS-986249 1600mg Q8WMonotherapy	6/11 (54.5%)	7/11 (63.6%)	9/11 (81.8%)
Part 1B: BMS-986249 240mg Q4W + Nivolumab Combination	11/12 (91.7%)	8/12 (66.7%)	12/12 (100%)
Part 1B: BMS-986249 800mg Q4W + Nivolumab Combination	8/11 (72.7%)	7/11 (63.6%)	11/11 (100%)
Part 1B: BMS-986249 1200mg Q4W + Nivolumab Combination	7/9 (77.8%)	7/9 (77.8%)	9/9 (100%)
Part 1B: BMS-986249 800mg Q8W+ Nivolumab Combination	8/13 (61.5%)	10/13 (76.9%)	12/13 (92.3%)
Part 1B: BMS-986249 1200mg Q8W+ Nivolumab Combination	4/9 (44.4%)	7/9 (77.8%)	9/9 (100%)
Part 1B: BMS-986249 1600mg Q8W+ Nivolumab Combination	9/10 (90%)	8/10 (80%)	10/10 (100%)
Part 2A: Melanoma Arms BMS-986249 240mg IV Q3W	0/3 (0%)	3/3 (100%)	3/3 (100%)
Part 2A: Melanoma Arms BMS-986249 800mg IV Q3W	2/3 (66.7%)	1/3 (33.3%)	3/3 (100%)
Part 2A: Melanoma Arms BMS-986249 1200mg IV Q3W	29/57 (50.9%)	42/57 (73.7%)	57/57 (100%)
Part 2A: Melanoma Arms Ipilimumab 3mg/kg IV Q3W	24/58 (41.4%)	28/58 (48.3%)	57/58 (98.3%)
Part 2A: Melanoma Arms Nivolumab Mono	1/3 (33.3%)	1/3 (33.3%)	3/3 (100%)
Part 2A: Melanoma Arms BMS-986249 600mg IV Q8W	11/36 (30.6%)	20/36 (55.6%)	34/36 (94.4%)
Part 2B: Cohort 1 (HCC)	4/5 (80%)	5/5 (100%)	5/5 (100%)
Part 2B: Cohort 2 (Metastatic CRPC)	26/41 (63.4%)	29/41 (70.7%)	39/41 (95.1%)
Part 2B: Cohort 3 (Unresectable TNBC)	28/45 (62.2%)	25/45 (55.6%)	45/45 (100%)

Most frequent serious events

Showing 10 of 168

Most frequent serious events
Event	Part 1A: BMS-986249 240mg Monotherapy	Part 1A: BMS-986249 800mg Monotherapy	Part 1A: BMS-986249 1600mg Q4W Monotherapy	Part 1A: BMS-986249 2400mg Monotherapy	Part 1A: BMS-986249 1600mg Q8WMonotherapy	Part 1B: BMS-986249 240mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 1200mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1200mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arms BMS-986249 240mg IV Q3W	Part 2A: Melanoma Arms BMS-986249 800mg IV Q3W	Part 2A: Melanoma Arms BMS-986249 1200mg IV Q3W	Part 2A: Melanoma Arms Ipilimumab 3mg/kg IV Q3W	Part 2A: Melanoma Arms Nivolumab Mono	Part 2A: Melanoma Arms BMS-986249 600mg IV Q8W	Part 2B: Cohort 1 (HCC)	Part 2B: Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)	3/6	6/11	1/10	1/1	1/11	3/12	4/11	5/9	3/13	2/9	2/10	0/3	0/3	6/57	6/58	1/3	3/36	1/5	4/41	2/45
ColitisGastrointestinal disorders	0/6	1/11	2/10	0/1	0/11	1/12	0/11	2/9	0/13	2/9	2/10	1/3	0/3	2/57	0/58	0/3	2/36	2/5	2/41	0/45
HypophysitisEndocrine disorders	0/6	0/11	0/10	0/1	0/11	0/12	0/11	0/9	0/13	0/9	1/10	1/3	0/3	1/57	1/58	0/3	1/36	0/5	0/41	0/45
VomitingGastrointestinal disorders	0/6	0/11	0/10	0/1	0/11	0/12	0/11	1/9	1/13	0/9	0/10	1/3	0/3	1/57	0/58	0/3	0/36	0/5	0/41	0/45
COVID-19 pneumoniaInfections and infestations	0/6	0/11	0/10	0/1	0/11	0/12	0/11	0/9	0/13	0/9	0/10	0/3	1/3	1/57	0/58	0/3	0/36	0/5	0/41	0/45
Hip fractureInjury, poisoning and procedural complications	0/6	0/11	0/10	0/1	0/11	0/12	0/11	0/9	0/13	0/9	0/10	0/3	1/3	0/57	0/58	0/3	0/36	0/5	0/41	0/45
Neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/6	0/11	0/10	0/1	1/11	0/12	0/11	0/9	0/13	0/9	0/10	1/3	0/3	0/57	0/58	0/3	0/36	0/5	0/41	0/45
Renal failureRenal and urinary disorders	0/6	0/11	0/10	0/1	0/11	0/12	0/11	0/9	0/13	0/9	0/10	0/3	0/3	1/57	0/58	1/3	0/36	1/5	0/41	0/45
DyspnoeaRespiratory, thoracic and mediastinal disorders	0/6	0/11	0/10	0/1	0/11	1/12	0/11	0/9	0/13	0/9	0/10	1/3	0/3	1/57	0/58	0/3	0/36	1/5	1/41	0/45
FatigueGeneral disorders	0/6	0/11	0/10	0/1	1/11	0/12	0/11	2/9	0/13	0/9	0/10	0/3	0/3	0/57	0/58	0/3	0/36	0/5	0/41	0/45

Most frequent other events

Showing 10 of 299

Most frequent other events
Event	Part 1A: BMS-986249 240mg Monotherapy	Part 1A: BMS-986249 800mg Monotherapy	Part 1A: BMS-986249 1600mg Q4W Monotherapy	Part 1A: BMS-986249 2400mg Monotherapy	Part 1A: BMS-986249 1600mg Q8WMonotherapy	Part 1B: BMS-986249 240mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 1200mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1200mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arms BMS-986249 240mg IV Q3W	Part 2A: Melanoma Arms BMS-986249 800mg IV Q3W	Part 2A: Melanoma Arms BMS-986249 1200mg IV Q3W	Part 2A: Melanoma Arms Ipilimumab 3mg/kg IV Q3W	Part 2A: Melanoma Arms Nivolumab Mono	Part 2A: Melanoma Arms BMS-986249 600mg IV Q8W	Part 2B: Cohort 1 (HCC)	Part 2B: Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)
Abdominal painGastrointestinal disorders	3/6	1/11	1/10	1/1	2/11	5/12	1/11	0/9	3/13	2/9	2/10	1/3	1/3	10/57	3/58	0/3	4/36	0/5	3/41	8/45
FatigueGeneral disorders	1/6	4/11	7/10	0/1	2/11	9/12	6/11	6/9	7/13	6/9	5/10	0/3	3/3	15/57	19/58	0/3	9/36	4/5	18/41	13/45
HyperbilirubinaemiaHepatobiliary disorders	0/6	0/11	0/10	1/1	0/11	0/12	0/11	0/9	1/13	0/9	1/10	0/3	0/3	1/57	1/58	0/3	0/36	0/5	0/41	0/45
Upper respiratory tract infectionInfections and infestations	0/6	1/11	0/10	1/1	1/11	1/12	1/11	1/9	0/13	1/9	0/10	0/3	0/3	0/57	1/58	0/3	0/36	0/5	0/41	0/45
Aspartate aminotransferase increasedInvestigations	1/6	2/11	1/10	1/1	1/11	2/12	1/11	2/9	1/13	3/9	2/10	0/3	2/3	21/57	25/58	0/3	10/36	2/5	8/41	17/45
C-reactive protein increasedInvestigations	0/6	0/11	0/10	1/1	0/11	0/12	0/11	0/9	0/13	0/9	0/10	0/3	0/3	1/57	1/58	0/3	0/36	0/5	0/41	1/45
Haemoglobin decreasedInvestigations	0/6	0/11	0/10	1/1	0/11	0/12	0/11	0/9	0/13	0/9	0/10	0/3	0/3	0/57	2/58	0/3	1/36	0/5	0/41	1/45
Lipase increasedInvestigations	0/6	2/11	1/10	1/1	0/11	3/12	0/11	1/9	2/13	0/9	1/10	0/3	2/3	11/57	13/58	1/3	7/36	0/5	5/41	8/45
Liver function test increasedInvestigations	0/6	0/11	0/10	1/1	0/11	0/12	0/11	0/9	0/13	0/9	0/10	0/3	0/3	0/57	0/58	0/3	0/36	0/5	0/41	0/45
HypomagnesaemiaMetabolism and nutrition disorders	0/6	2/11	2/10	1/1	1/11	1/12	0/11	0/9	2/13	0/9	3/10	0/3	0/3	1/57	2/58	0/3	0/36	0/5	2/41	3/45

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm A: BMS-986249 240 mg Q3W + Nivolumab 360 mg Q3W	Part 2A: Melanoma Arm B: BMS-986249 800 mg + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm E: Nivolumab 480 mg Q4W Monotherapy	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Total
Mean	54.0 ± 18.9	64.8 ± 7.5	60.4 ± 10.2	64 ± NA	60.3 ± 11.6	56.3 ± 8.8	53.9 ± 12.4	61.4 ± 11.2	55.3 ± 11.4	59.0 ± 8.0	60.1 ± 9.9	60.7 ± 13.6	73.3 ± 7.6	61.4 ± 14.7	57.3 ± 13.8	59.7 ± 24.8	60.3 ± 12.4	60.4 ± 9.8	68.6 ± 8.0	51.2 ± 12.8	59.4 ± 13.0

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm A: BMS-986249 240 mg Q3W + Nivolumab 360 mg Q3W	Part 2A: Melanoma Arm B: BMS-986249 800 mg + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm E: Nivolumab 480 mg Q4W Monotherapy	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Total
Female	3	8	8	0	7	9	4	1	4	5	4	1	1	22	27	1	19	1	0	45	170
Male	3	3	2	1	4	3	7	8	9	4	6	2	2	36	32	2	17	4	41	0	186

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm A: BMS-986249 240 mg Q3W + Nivolumab 360 mg Q3W	Part 2A: Melanoma Arm B: BMS-986249 800 mg + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm E: Nivolumab 480 mg Q4W Monotherapy	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Total
Hispanic or Latino	1	1	0	1	2	2	1	0	1	0	2	0	1	7	11	0	2	1	3	3	39
Not Hispanic or Latino	5	10	8	0	7	10	10	6	10	8	6	3	1	11	8	1	11	1	6	13	135
Unknown or Not Reported	0	0	2	0	2	0	0	3	2	1	2	0	1	40	40	2	23	3	32	29	182

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arm A: BMS-986249 240 mg Q3W + Nivolumab 360 mg Q3W	Part 2A: Melanoma Arm B: BMS-986249 800 mg + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm C: BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2A: Melanoma Arm D: Ipilimumab 3 mg/kg Q3W + Nivolumab 1 mg/kg Q3W	Part 2A: Melanoma Arm E: Nivolumab 480 mg Q4W Monotherapy	Part 2A: Melanoma Arm F: BMS-986249 600 mg Q4W + Nivolumab 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg IV Q4W	Part 2B: Cohort 2 (Metastatic CRPC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Part 2B: Cohort 3 (Unresectable TNBC): BMS-986249 1200 mg Q8W + Nivolumab 480 mg Q4W	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Asian	0	0	1	0	0	0	0	0	2	0	0	0	0	0	2	0	0	0	0	0	5
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Black or African American	1	0	1	0	2	0	0	1	2	0	0	0	0	1	0	0	0	0	0	1	9
White	4	11	7	1	8	11	11	6	9	9	10	3	3	57	57	3	36	5	40	44	335
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	1	0	1	0	1	1	0	2	0	0	0	0	0	0	0	0	0	0	1	0	7

Study locations

45 sites

Local Institution - 0005
Aurora, Colorado 80045, United States
Local Institution - 0006
Denver, Colorado 80218, United States
Local Institution - 0017
Miami, Florida 33176, United States
Local Institution - 0024
Baltimore, Maryland 21287, United States
Local Institution - 0001
Hackensack, New Jersey 07601, United States
Local Institution - 0002
New York, New York 10032, United States
Local Institution - 0003
New York, New York 10065, United States
Local Institution - 0029
Cincinnati, Ohio 45219, United States
Local Institution - 0013
Eugene, Oregon 97401, United States
Local Institution - 0004
Philadelphia, Pennsylvania 19104, United States
Local Institution - 0008
Greenville, South Carolina 29605, United States
Local Institution - 0010
Austin, Texas 78705-1165, United States
Local Institution - 0009
Dallas, Texas 75246, United States
Local Institution - 0021
Houston, Texas 77030, United States
Local Institution - 0016
San Antonio, Texas 78240, United States
Local Institution - 0011
Tyler, Texas 75702, United States
Local Institution - 0012
Leesburg, Virginia 20176, United States
Local Institution - 0007
Norfolk, Virginia 23502, United States
Local Institution - 0018
Vancouver, Washington 98684, United States
Local Institution - 0038
Buenos Aires, Distrito Federal 1121, Argentina
Local Institution - 0052
CABA, Distrito Federal C1430, Argentina
Local Institution - 0037
Buenos Aires, C1426ANZ, Argentina
Local Institution - 0015
North Sydney, New South Wales 2060, Australia
Local Institution - 0014
Adelaide, South Australia 5000, Australia
Local Institution - 0025
Frankston, Victoria 3199, Australia
Local Institution - 0047
Heidelberg, Victoria 3084, Australia
Local Institution - 0026
Edmonton, Alberta T6G 1Z2, Canada
Local Institution - 0056
Ottawa, Ontario K1H 8L6, Canada
Local Institution - 0036
Santiago, Santiago Metropolitan 8420383, Chile
Local Institution - 0039
Helsinki, 00029, Finland
Local Institution - 0030
Essen, 45147, Germany
Local Institution - 0035
Hamburg, 20251, Germany
Local Institution - 0031
Heidelberg, 69120, Germany
Local Institution - 0048
Milan, 20133, Italy
Local Institution - 0020
Naples, 80131, Italy
Local Institution - 0049
Siena, 53100, Italy
Local Institution - 0040
Warsaw, 02-781, Poland
Local Institution - 0045
Bucharest, 022328, Romania
Local Institution - 0041
Craiova, 200542, Romania
Local Institution - 0042
Badalona, Barcelona [Barcelona] 08916, Spain
Local Institution - 0022
Madrid, Madrid, Comunidad de 28027, Spain
Local Institution - 0044
Barcelona, 08035, Spain
Local Institution - 0023
Madrid, 28040, Spain
Local Institution - 0050
Madrid, 28041, Spain
Local Institution - 0043
Málaga, 29010, Spain

References and documents

Study documents

Protocol and statistical analysis plan · Mar 14, 2023

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03369223
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Dec 11, 2017
Start date: Dec 6, 2017
Primary completion: Nov 7, 2024
Completion: Nov 7, 2024
Results posted: Nov 18, 2025
Last update: Nov 18, 2025

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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