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NCT00636168 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,211
- Enrollment target
NCT00636168: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00636168 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,211 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00636168, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,211 participants
- Enrollment target
Study Summary
The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma
Primary Outcome
Recurrence free survival (RFS) was programmatically determined based on the disease recurrence data provided by the IRC and was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A participant who died without reported recurrence was considered to have recurrence on the date of death. For those participants who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-random
Interventions
- DRUG Placebo
- DRUG ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,211 participants |
| Start Date | 2008-06-30 |
| Est. Completion | 2018-11-26 |
| Phase | Phase 3 |
What the finished NCT00636168 record still lists
NCT00636168 is an interventional study that assigns participants to a tested intervention. Its 1,211 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 (57% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00636168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00636168 about?
NCT00636168 is a clinical study titled "Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma". The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma
What is the current status of trial NCT00636168?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,211 participants. The study started on 2008-06-30. Estimated completion is 2018-11-26.
What interventions are being tested in trial NCT00636168?
The interventions under investigation include: Placebo (DRUG), ipilimumab (DRUG).
Who is sponsoring clinical trial NCT00636168?
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 NCT00636168's enrollment target sits among peer trials
1,211 216th of 2000 higher than 1,785 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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