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NCT01515189 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 831
- Enrollment target
NCT01515189: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01515189 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 831 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
NCT01515189, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 831 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg
Primary Outcome
OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.
Interventions
- BIOLOGICAL Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 831 participants |
| Start Date | 2012-02-17 |
| Est. Completion | 2017-08-17 |
| Phase | Phase 3 |
What the finished NCT01515189 record still lists
NCT01515189 is an interventional study that assigns participants to a tested intervention. The registered 831 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 1 intervention - of which Ipilimumab is the first listed.
NCT01515189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01515189 about?
NCT01515189 is a clinical study titled "Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab". The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg
What is the current status of trial NCT01515189?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 831 participants. The study started on 2012-02-17. Estimated completion is 2017-08-17.
What interventions are being tested in trial NCT01515189?
The interventions under investigation include: Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01515189?
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 NCT01515189's enrollment target sits among peer trials
831 397th of 2000 higher than 1,603 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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