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NCT01668784 · ClinicalTrials.gov registry record · Phase 3
Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 821
- Enrollment target
NCT01668784: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01668784 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 821 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01668784, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 821 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy
Primary Outcome
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p \< 0.0148) was crossed while no new safe
Interventions
- DRUG Everolimus
- BIOLOGICAL Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 821 participants |
| Start Date | 2012-10-09 |
| Est. Completion | 2021-07-19 |
| Phase | Phase 3 |
What the finished NCT01668784 record still lists
NCT01668784 is an interventional study that assigns participants to a tested intervention. The registered 821 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT01668784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01668784 about?
NCT01668784 is a clinical study titled "Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)". The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy
What is the current status of trial NCT01668784?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 821 participants. The study started on 2012-10-09. Estimated completion is 2021-07-19.
What interventions are being tested in trial NCT01668784?
The interventions under investigation include: Everolimus (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01668784?
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 NCT01668784's enrollment target sits among peer trials
821 404th of 2000 higher than 1,597 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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