Trials / Active Not Recruiting
Active Not RecruitingNCT03873402
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 437 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
| BIOLOGICAL | Ipilimumab | Specified dose on specified days |
| OTHER | Ipilimumab placebo | Specified dose on specified days |
Timeline
- Start date
- 2019-06-21
- Primary completion
- 2027-03-11
- Completion
- 2027-03-11
- First posted
- 2019-03-13
- Last updated
- 2026-01-21
Locations
78 sites across 14 countries: United States, Argentina, Austria, Chile, Czechia, France, Greece, Italy, Mexico, Poland, Portugal, Romania, Russia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03873402. Inclusion in this directory is not an endorsement.