Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 do...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05407675
Start Date
August 2 2022
End Date
July 24 2025
Last Update
October 3 2025
Active Locations (18)
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1
Local Institution - 0010
Boston, Massachusetts, United States, 02215
2
Local Institution - 0001
Hackensack, New Jersey, United States, 07601
3
Local Institution - 0003
Houston, Texas, United States, 77030
4
Local Institution - 0007
Edmonton, Alberta, Canada, T6G 1Z2