A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.

Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Advanced Solid Tumors
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
100
Est. Completion Date
Jul 1, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov NCT Identifier
NCT05888831
Study Number
CA120-1001
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