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NCT01927419 · ClinicalTrials.gov registry record · Phase 2
Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
NCT01927419: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01927419 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 142 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01927419, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
Study Summary
The primary purpose of this study is to compare the objective response rate, as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in patients with untreated, unresectable, or metastatic melanoma
Primary Outcome
Objective Response Rate is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), assessed by the investigator by using RECIST 1.1 criteria. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (\<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Interventions
- DRUG Placebo
- DRUG Nivolumab
- DRUG Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2013-08-23 |
| Est. Completion | 2021-02-26 |
| Phase | Phase 2 |
What the finished NCT01927419 record still lists
NCT01927419 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01927419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01927419 about?
NCT01927419 is a clinical study titled "Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma". The primary purpose of this study is to compare the objective response rate, as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in patients with untreated, unresectable, or metastatic melanoma
What is the current status of trial NCT01927419?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2013-08-23. Estimated completion is 2021-02-26.
What interventions are being tested in trial NCT01927419?
The interventions under investigation include: Placebo (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT01927419?
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 NCT01927419's enrollment target sits among peer trials
142 507th of 2000 higher than 1,491 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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