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

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

ClinicalTrials.gov ID

NCT03369223

Acronym / sponsor ID

CA030-001

Conditions

Advanced Cancer

Keywords

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

Phase

Phase 1/2

Study type

Interventional

Recruitment status

Completed

Enrolment

356 participants (actual)

Lead sponsor

Bristol-Myers SquibbIndustry (pharma, biotech, devices)

Study start

6 Dec 2017 (actual)

Primary completion

7 Nov 2024 (actual)

Study completion

7 Nov 2024 (actual)

First posted

11 Dec 2017 (actual)

Results

Posted 18 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

11

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

   Time frame: 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.

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

   Time frame: 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).

3. Number of Participants Who Died - Part 1 A and 1 B

   Time frame: From enrollment until the date of death from any cause (up to approximately 83 months)

   Number of Participants who Died

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

   Time frame: 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

5. 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

   Time frame: 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.

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

   Time frame: 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• BMS Clinical Trial InformationLink provided by the sponsor.
• BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

45 sites in 11 countries: see every site and its status.