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
- Interventions
- Biological: Platinum-doublet chemotherapy
- Registration Number
- NCT05407675
- Lead Sponsor
- Bristol-Myers Squibb
- 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 dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 101
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2: BMS-986408 in combination with nivolumab and chemotherapy BMS-986408 - Part 2: BMS-986408 in combination with nivolumab and ipilimumab Nivolumab - Part 2: BMS-986408 in combination with nivolumab Nivolumab - Part 3: BMS-986408 in combination with nivolumab and chemotherapy Platinum-doublet chemotherapy - Part 2: BMS-986408 in combination with rabeprazole Rabeprazole - Part 2: BMS-986408 in combination with nivolumab and ipilimumab Ipilimumab - Part 2: BMS-986408 in combination with nivolumab and chemotherapy Platinum-doublet chemotherapy - Part 2: BMS-986408 in combination with nivolumab and chemotherapy Nivolumab - Part 3: BMS-986408 in combination with nivolumab Nivolumab - Part 2: BMS-986408 in combination with nivolumab BMS-986408 - Part 3: BMS-986408 in combination with nivolumab BMS-986408 - Part 2: BMS-986408 in combination with nivolumab and ipilimumab BMS-986408 - Part 1: BMS-986408 Monotherapy BMS-986408 - Part 2: BMS-986408 in combination with rabeprazole BMS-986408 - Part 3: BMS-986408 in combination with nivolumab and chemotherapy BMS-986408 - Part 3: BMS-986408 in combination with nivolumab and chemotherapy Nivolumab -
- Primary Outcome Measures
Name Time Method Number of deaths Up to 50 months Number of participants with Dose-Limiting Toxicities (DLTs) Up to 28 days Number of participants with Adverse Events (AEs) Up to 29 months
- Secondary Outcome Measures
Name Time Method Maximum concentration (Cmax) Up to 27 months Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T)) Up to 27 months Objective Response Rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to 50 months Duration of Response (DOR) assessed by RECIST v1.1 Up to 50 months Time of maximum observed concentration (Tmax) Up to 27 months
Trial Locations
- Locations (18)
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, AndalucÃa, Spain
Local Institution - 0025
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0022
🇪🇸Madrid, Spain
Local Institution - 0023
🇪🇸Madrid, Spain
Local Institution - 0021
🇨ðŸ‡st.Gallen, Sankt Gallen, Switzerland
Local Institution - 0012
🇨ðŸ‡Basel, Switzerland
Local Institution - 0020
🇨ðŸ‡Geneva, Switzerland