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NCT00324155 · ClinicalTrials.gov registry record · Phase 3
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 681
- Enrollment target
NCT00324155: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00324155 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 681 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00324155, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 681 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration \[FDA\]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine
Primary Outcome
OS was defined as the time from the date of randomization until the date of death. Analysis of OS was to be done once 416 deaths had occurred (primary endpoint). However, analysis occurred at 414 deaths (February 7, 2011), due to operational timing of the study. Median number of months of OS and associated confidence interval calculated using the method of Brookmeyer and Crowley.
Interventions
- DRUG Placebo
- DRUG Ipilimumab
- DRUG Dacarbazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 681 participants |
| Start Date | 2006-08 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT00324155 record still lists
NCT00324155 is an interventional study that assigns participants to a tested intervention. The registered 681 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00324155 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00324155 about?
NCT00324155 is a clinical study titled "Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma". The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administrati...
What is the current status of trial NCT00324155?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 681 participants. The study started on 2006-08. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00324155?
The interventions under investigation include: Placebo (DRUG), Ipilimumab (DRUG), Dacarbazine (DRUG).
Who is sponsoring clinical trial NCT00324155?
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 NCT00324155's enrollment target sits among peer trials
681 530th of 2000 higher than 1,469 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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