Trials / Completed
CompletedNCT05407675
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
A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-986408 | Specified dose on specified days |
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
| BIOLOGICAL | Ipilimumab | Specified dose on specified days |
| BIOLOGICAL | Platinum-doublet chemotherapy | Specified dose on specified days |
| DRUG | Rabeprazole | Specified dose on specified days |
Timeline
- Start date
- 2022-08-02
- Primary completion
- 2024-08-22
- Completion
- 2025-07-24
- First posted
- 2022-06-07
- Last updated
- 2025-10-03
- Results posted
- 2025-10-03
Locations
18 sites across 5 countries: United States, Canada, France, Spain, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05407675. Inclusion in this directory is not an endorsement.