Active Not RecruitingPhase 1 / Phase 2NCT05888831

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

StatusActive Not Recruiting
PhasePhase 1 / Phase 2
U.S. locations20
SponsorBristol-Myers Squibb
01
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
02
Explore related studies

How this study is categorized

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

Treatment approach
03
Public criteria

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.

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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.

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