A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

Study summary

The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBMS-986449 and Nivolumab

The study team can explain what participation involves.

Who it may be forAdvanced Solid Tumors

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 11, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?20 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Bristol-Myers Squibb
Interventions being studied: Drug: BMS-986449; Drug: Nivolumab

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.
Part 1A may have a solid malignancy of any histology.
Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).
Tumor biopsy must be obtained for all participants (unless medically precluded).

Reasons someone may not be able to joinExclusion criteria

History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], or anti-PD- 1/programmed death-ligand 1 \[PD-L1\] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator. Other protocol-defined criteria may apply.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Local Institution - 0021Los Angeles, California
Local Institution - 0007New Haven, Connecticut
Local Institution - 0010Hackensack, New Jersey
Local Institution - 0022Lake Success, New York
Local Institution - 0016Brussels, Bruxelles-Capitale, Région de
Local Institution - 0017Ghent, Oost-Vlaanderen
Local Institution - 0002Villejuif, Paris
Local Institution - 0004Marseille, Provence-Alpes-Côte d'Azur Region
Local Institution - 0003Bordeaux
Local Institution - 0023Rozzano, Milano
Local Institution - 0024Siena, Tuscany
Local Institution - 0026Bergamo

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 11, 2025. Always confirm current availability with the study team.

View original record ↗