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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with Dose-Limiting Toxicities (DLTs) — Up to approximately 4 years
Number of participants with Adverse Events (AEs) — Up to approximately 4 years
Number of participants with Serious Adverse Events (SAEs) — Up to approximately 4 years
Number of participants with AEs leading to discontinuation — Up to approximately 4 years
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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