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NCT02231749 · ClinicalTrials.gov registry record · Phase 3
Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,096
- Enrollment target
NCT02231749: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT02231749 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,096 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02231749, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,096 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.
Primary Outcome
ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on Independent Radiology Review Committee (IRRC) assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diame
Interventions
- DRUG Sunitinib
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,096 participants |
| Start Date | 2014-10-16 |
| Est. Completion | 2025-03-21 |
| Phase | Phase 3 |
What the finished NCT02231749 record still lists
NCT02231749 is an interventional study that assigns participants to a tested intervention. Its 1,096 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 3 interventions - of which Sunitinib is the first listed.
NCT02231749 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02231749 about?
NCT02231749 is a clinical study titled "Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)". The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.
What is the current status of trial NCT02231749?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,096 participants. The study started on 2014-10-16. Estimated completion is 2025-03-21.
What interventions are being tested in trial NCT02231749?
The interventions under investigation include: Sunitinib (DRUG), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02231749?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02231749's enrollment target sits among peer trials
1,096 265th of 2000 higher than 1,736 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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