Trials / Completed
CompletedNCT03635983
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 783 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | NKTR-214 | Specified dose on specified days |
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
Timeline
- Start date
- 2018-09-21
- Primary completion
- 2021-11-19
- Completion
- 2024-03-19
- First posted
- 2018-08-17
- Last updated
- 2025-04-01
- Results posted
- 2022-12-19
Locations
167 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03635983. Inclusion in this directory is not an endorsement.