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NCT01354431 · ClinicalTrials.gov registry record · Phase 2
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
NCT01354431: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01354431 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 168 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01354431, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
Study Summary
The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.
Primary Outcome
PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator'
Interventions
- BIOLOGICAL nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2011-05-31 |
| Est. Completion | 2021-04-15 |
| Phase | Phase 2 |
What the finished NCT01354431 record still lists
NCT01354431 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 1 intervention - of which nivolumab is the first listed.
NCT01354431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01354431 about?
NCT01354431 is a clinical study titled "BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)". The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.
What is the current status of trial NCT01354431?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2011-05-31. Estimated completion is 2021-04-15.
What interventions are being tested in trial NCT01354431?
The interventions under investigation include: nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01354431?
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 NCT01354431's enrollment target sits among peer trials
168 403rd of 2000 higher than 1,595 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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