A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT04943900
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BMS-986416 — DRUGSpecified dose on specified days
- Nivolumab — DRUGSpecified dose on specified days
Study Details
The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.
Key Dates
- Start date
- Aug 9, 2021
- Status verified
- Apr 2025
- Primary completion
- Feb 27, 2025
- Completion
- Feb 27, 2025
Study Design
- Enrollment
- 67 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1A: Monotherapy (BMS-986416)
- Experimental: Part 1B: Combination Therapy (BMS-986416 + Nivolumab)
Primary Outcome Measure
Incidence of Adverse Events (AEs) [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0006 | Atlanta | Georgia | 30322 | - |
| Local Institution - 0005 | Baltimore | Maryland | 21287 | - |
| Local Institution - 0002 | Hackensack | New Jersey | 07601 | - |
| Local Institution - 0013 | Cleveland | Ohio | 44106-1716 | - |
| Local Institution - 0003 | Pittsburgh | Pennsylvania | 15232 | - |
| Local Institution - 0004 | Houston | Texas | 77030 | - |
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