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NCT03937219 · ClinicalTrials.gov record · last posted 2025-09-10

Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Study acronym: COSMIC-313
StatusActive, Not Recruiting
PhasePhase 3
SponsorExelixis
Started2019-06-25
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 43 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 43 times since 2019-05-02; most recent amendment 2025-08-22. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-02-07
Status change Completed→Active, Not Recruitingv42
2024-10-28
Status change Active, Not Recruiting→Completedv39
2021-03-30
Status change Recruiting→Active, Not Recruitingv33
2020-12-19
Status change Active, Not Recruiting→Recruitingv31
2020-11-04
Status change Recruiting→Active, Not Recruitingv25
2019-07-02
Status change Not Yet Recruiting→Recruitingv4
Trial Details
NCT Number NCT03937219
Lead Sponsor Exelixis
Conditions Renal Cell Carcinoma
Enrollment 855 participants
Start Date 2019-06-25
Primary Completion 2022-01-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-10