CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 855 enrolled
Drug / intervention
Cabozantinib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03937219
NCT03937219Phase 3Active
CompareCT.gov

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

Exelixis·interventional·Posted May 3, 2019·Updated Sep 10, 2025

In Brief

A Phase 3 clinical trial evaluating Cabozantinib, Nivolumab, and 2 other interventions for Renal Cell Carcinoma. Active but no longer recruiting, targeting 855 participants across 159 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3Active
20202021202220232024202520262027
First PostedMay 3, 2019
Enrollment StartJun 25, 2019
Primary CompletionJan 31, 2022
Study CompletionJan 31, 2027
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.2 years ago

Interventions

Cabozantinibdrug

Specified dose on specified days.

Nivolumabbiological

Specified dose on specified days.

Ipilimumabbiological

Specified dose on specified days.

Cabozantinib-matched placebodrug

Specified dose on specified days.