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

Completed · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

Key facts

Study ID

NCT05407675

Run by

Bristol-Myers Squibb

People needed

68

Starts

2022-08-02

Expected to finish

2025-07-24

Last updated by the study team

2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0010 — Boston, Massachusetts, United States
• Local Institution - 0001 — Hackensack, New Jersey, United States
• Local Institution - 0003 — Houston, Texas, United States
• Local Institution - 0007 — Edmonton, Alberta, Canada
• Local Institution - 0011 — Hamilton, Ontario, Canada
• Local Institution - 0005 — Ottawa, Ontario, Canada
• Local Institution - 0006 — Toronto, Ontario, Canada
• Local Institution - 0015 — Bordeaux, Aquitaine, France
• Local Institution - 0014 — Villejuif, Paris, France
• Local Institution - 0018 — Marseille, France
• Local Institution - 0019 — Toulouse, France
• Local Institution - 0024 — Málaga, Andalusia, Spain
• Local Institution - 0025 — Madrid, Madrid, Comunidad de, Spain
• Local Institution - 0022 — Madrid, Spain
• Local Institution - 0023 — Madrid, Spain
• Local Institution - 0021 — Sankt Gallen, Canton of St. Gallen, Switzerland
• Local Institution - 0012 — Basel, Switzerland
• Local Institution - 0020 — Geneva, Switzerland

Full record on ClinicalTrials.gov

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