A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors
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.
Checked against the public recordLast updated Jun 11, 2025 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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). Exclusion 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.
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.