A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT03978611
- Phase
- PHASE1
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Relatlimab — DRUGSpecified dose on specified days
- Ipilimumab — DRUGSpecified dose on specified days
Study Details
The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.
Key Dates
- Start date
- Dec 9, 2021
- Status verified
- Jul 2024
- Primary completion
- Jul 26, 2023
- Completion
- Jul 26, 2023
Study Design
- Enrollment
- 11 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1: Dose Escalation Phase
Primary Outcome Measure
Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0023 | Tucson | Arizona | 85724 | - |
| Local Institution - 0002 | Los Angeles | California | 90033 | - |
| Local Institution - 0005 | Los Angeles | California | 90033 | - |
| Local Institution - 0001 | Santa Monica | California | 90404 | - |
| Local Institution - 0015 | Miami | Florida | 33136 | - |
| Local Institution - 0004 | Chicago | Illinois | 60611 | - |
| Local Institution - 0003 | Ann Arbor | Michigan | 48109 | - |
| Local Institution - 0008 | Morristown | New Jersey | 07960 | - |
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