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Recruiting

A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors - CA099-003

Updated: 29 January, 2024   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 15

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1: BMS-986408 Monotherapy
Drug: BMS-986408
Experimental: Part 2: BMS-986408 in combination with nivolumab
Biological: Nivolumab Drug: BMS-986408
Experimental: Part 2: BMS-986408 in combination with nivolumab and ipilimumab
Drug: BMS-986408 Biological: Ipilimumab, Nivolumab

Key Eligibility Criteria

Inclusion Criteria: - Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant - Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS) - Participants must have experienced radiographically documented progressive disease on or after the most recent therapy Exclusion Criteria: - An active, known or suspected autoimmune disease - Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment - Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug - Untreated central nervous system (CNS) metastases or leptomeningeal metastasis Other protocol-defined inclusion/exclusion criteria apply

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