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