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Completed NCT05407675

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

Conditions: Advanced Solid Tumors

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 68
Sponsor: Bristol-Myers Squibb

Location: Local Institution - 0010 Boston Massachusetts

Summary

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05407675). StuddyBuddy aggregates publicly available trial information.