Trials / Completed
CompletedNCT03980314
A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection
A Randomized, Double-Blind, Parallel, Phase 1 Study to Compare the Pharmacokinetics of BMSCHO1-Nivolumab Process D to Nivolumab Process C After Complete Resection of Stage IIIa/b/c/d or Stage IV Melanoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 261 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nivolumab | Specified dose on specified days |
Timeline
- Start date
- 2019-06-24
- Primary completion
- 2021-03-04
- Completion
- 2023-11-06
- First posted
- 2019-06-10
- Last updated
- 2023-12-15
Locations
37 sites across 14 countries: United States, Argentina, Australia, Brazil, Canada, Chile, France, Ireland, Italy, Mexico, New Zealand, Poland, Romania, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03980314. Inclusion in this directory is not an endorsement.