Trials / Active Not Recruiting
Active Not RecruitingNCT03937219
Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 855 (actual)
- Sponsor
- Exelixis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.
Detailed description
This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. The primary objective of this study is to evaluate the effect of cabozantinib in combination with nivolumab and ipilimumab ("triplet") on the duration of progression-free survival (PFS) versus nivolumab and ipilimumab. A secondary objective is to evaluate the effect of triplet combination on the duration of overall survival (OS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cabozantinib | Specified dose on specified days. |
| BIOLOGICAL | Nivolumab | Specified dose on specified days. |
| BIOLOGICAL | Ipilimumab | Specified dose on specified days. |
| DRUG | Cabozantinib-matched placebo | Specified dose on specified days. |
Timeline
- Start date
- 2019-06-25
- Primary completion
- 2022-01-31
- Completion
- 2027-01-31
- First posted
- 2019-05-03
- Last updated
- 2025-09-10
- Results posted
- 2025-09-10
Locations
159 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03937219. Inclusion in this directory is not an endorsement.