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Active, Not 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: 20 November, 2024   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
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

  • Active, Not 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
Drug: BMS-986408 Biological: Nivolumab
Experimental: Part 2: BMS-986408 in combination with nivolumab and chemotherapy
Biological: Platinum-doublet chemotherapy, Nivolumab Drug: BMS-986408
Experimental: Part 2: BMS-986408 in combination with nivolumab and ipilimumab
Drug: BMS-986408 Biological: Nivolumab, Ipilimumab
Experimental: Part 2: BMS-986408 in combination with rabeprazole
Drug: Rabeprazole, BMS-986408
Experimental: Part 3: BMS-986408 in combination with nivolumab
Drug: BMS-986408 Biological: Nivolumab
Experimental: Part 3: BMS-986408 in combination with nivolumab and chemotherapy
Biological: Platinum-doublet chemotherapy, Nivolumab Drug: BMS-986408

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

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001