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NCT03937219 · ClinicalTrials.gov registry record · Phase 3
Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
A Phase 3 study of Renal Cell Carcinoma, sponsored by Exelixis.
- Active
- Registry status
- Phase 3
- Development phase
- 855
- Enrollment target
- 20
- Study locations
NCT03937219: Active Phase 3 study of Renal Cell Carcinoma, sponsored by Exelixis.
NCT03937219 is a Phase 3 study of Renal Cell Carcinoma that is active but no longer recruiting, run by Exelixis. The registered enrollment target is 855 participants, above the 236-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (262% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03937219, a Phase 3 study of Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Exelixis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 855 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Duration of PFS was defined as the time from randomization to the earlier of either the date of radiographic progression per BIRC or the date of death due to any cause. PFS (months) = (earliest date of progression, death, censoring - date of randomization + 1)/30.4375. PFS was determined as per Response Evaluation Criteria in Solid Tumors version (RECIST) v1.1.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- DRUG Cabozantinib
- BIOLOGICAL Ipilimumab
- DRUG Cabozantinib-matched placebo
Study Locations (20)
Massachusetts
- Exelixis Clinical Site #7B - Boston
- Exelixis Clinical Site #7A - Boston
- Exelixis Clinical Site #7C - Boston
- Exelixis Clinical Site #6 - Burlington
New York
- Exelixis Clinical Site #159 - New York
- Exelixis Clinical Site #8 - New York
- Exelixis Clinical Site #19 - Syracuse
California
- Exelixis Clinical Site #116 - La Jolla
- Exelixis Clinical Site #166 - Orange
Florida
- Exelixis Clinical Site #29 - Boca Raton
- Exelixis Clinical Site #44 - Miami
Missouri
- Exelixis Clinical Site #24 - Kansas City
- Exelixis Clinical Site #4 - St Louis
Georgia
- Exelixis Clinical Site #3 - Atlanta
Illinois
- Exelixis Clinical Site #95 - Chicago
Maine
- Exelixis Clinical Site #69 - Scarborough
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 855 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 3 |
What the registry record for NCT03937219 still lists
NCT03937219 is an interventional study that assigns participants to a tested intervention. The registered 855 participants enrollment target is mid-sized for trials with a published cap, above the 236-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (262% higher).
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.
NCT03937219 names 20 study sites across 12 states, led by Massachusetts, New York, California.
Frequently Asked Questions
What is clinical trial NCT03937219 about?
NCT03937219 is a clinical study titled "Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma". 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...
What is the current status of trial NCT03937219?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 855 participants. The study started on 2019-06-25. Estimated completion is 2027-01-31.
What conditions does trial NCT03937219 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma.
What interventions are being tested in trial NCT03937219?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Cabozantinib (DRUG), Ipilimumab (BIOLOGICAL), Cabozantinib-matched placebo (DRUG).
Who is sponsoring clinical trial NCT03937219?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03937219 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Renal Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03937219's enrollment target sits among peer trials
855 7th of 121 higher than 115 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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