A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
Part of paid clinical trials in Fort Wayne, Indiana.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT05297565
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab/rHuPH20 — BIOLOGICALSpecified dose on specified days
- Nivolumab — BIOLOGICALSpecified dose on specified days
Study Details
The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.
Key Dates
- Start date
- Aug 2, 2022
- Status verified
- Feb 2025
- Primary completion
- Feb 8, 2024
- Completion
- Feb 8, 2024
Study Design
- Enrollment
- 14 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: Subcutaneous Nivolumab
- Active Comparator: Arm B: Intravenous Nivolumab
Primary Outcome Measure
Number of Participants With Adverse Events [ Time Frame: From first dose to 100 days post last dose (Approximately up to 14 Months) ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0004 | Fort Wayne | Indiana | 46804 | - |
| Local Institution - 0044 | Knoxville | Tennessee | 37920 | - |
Related coverage on Hipa.ai
- Nivolumab Subcutaneous vs IV Safety Assessed in Melanoma TrialNivolumab · Feb 27, 2025 · ClinicalTrials.gov
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