Trials / Completed
CompletedNCT05297565
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab/rHuPH20 | Specified dose on specified days |
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
Timeline
- Start date
- 2022-08-02
- Primary completion
- 2024-02-08
- Completion
- 2024-02-08
- First posted
- 2022-03-28
- Last updated
- 2025-02-27
- Results posted
- 2025-02-27
Locations
16 sites across 7 countries: United States, Australia, Belgium, Italy, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05297565. Inclusion in this directory is not an endorsement.