Trials / Completed
CompletedNCT01844505
Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)
A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 945 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab | |
| BIOLOGICAL | Ipilimumab | |
| BIOLOGICAL | Placebo for Nivolumab | |
| BIOLOGICAL | Placebo for Ipilimumab |
Timeline
- Start date
- 2013-06-11
- Primary completion
- 2016-08-01
- Completion
- 2024-04-19
- First posted
- 2013-05-01
- Last updated
- 2025-05-21
- Results posted
- 2017-09-26
Locations
150 sites across 22 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01844505. Inclusion in this directory is not an endorsement.