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BMS-986249

Phase 1

Advanced Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 18, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment356
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03369223A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid TumorsPHASE1 COMPLETED 356Dec 6, 2017Nov 7, 2024Nov 18, 202545 United States, Argentina +9
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B
From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

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.

Number of Participants With Adverse Events (AEs) Meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B
From first dose until 5 weeks after first dose of study medicine (up to approximately 5 weeks)

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).

Number of Participants Who Died - Part 1 A and 1 B
From enrollment until the date of death from any cause (up to approximately 83 months)

Number of Participants who Died

Number of Participants With Shifts From Baseline in Laboratory Tests Results - Part 1 A and 1 B
From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

Number of Participants with Shifts from Baseline in Laboratory Tests

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
From first dose until 24 weeks after first dose (up to approximately 24 weeks)

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.

Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F
From randomization until progression or death from any cause (up to approximately 83 months)

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.

Secondary Endpoints
Time to Deterioration in Part 2A (Arm C, D and F)
Approximately up to 6 months
Safety Related Events in Part 2A (Arm C, D and F) and 2B
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
From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A: BMS-986249EXPERIMENTAL -
Part 1B: BMS-986249 + nivolumab (nivo)EXPERIMENTAL -
Part 2A Arm C: BMS-986249 + nivoEXPERIMENTALPreviously untreated unresectable stage III-IV melanoma
Part 2A Arm D: ipilimumab + nivo then nivoEXPERIMENTALPreviously untreated unresectable stage III-IV melanoma
Part 2A Arm F: BMS-986249 + nivoEXPERIMENTALPreviously untreated unresectable stage III-IV melanoma
Part 2B Cohort 1: BMS-986249 + nivoEXPERIMENTALAdvanced or intermediate hepatocellular carcinoma (HCC)
Part 2B Cohort 2: BMS-986249 + nivoEXPERIMENTALMetastatic castration-resistant prostate cancer (CRPC)
Part 2B Cohort 3: BMS-986249 + nivoEXPERIMENTALUnresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
Part 2A Arm A: BMS-986249 + nivo then nivoEXPERIMENTAL* Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm
Part 2A Arm B: BMS-986249 + nivoEXPERIMENTAL* Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm
Part 2A Arm E: NivoEXPERIMENTAL* Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm
Interventions
NameTypeDescription
BMS-986249BIOLOGICALSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
IpilimumabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites45

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 cance...

Countries:United StatesArgentinaAustraliaCanadaChileFinlandGermanyItalyPolandRomaniaSpain
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