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NCT00094653 · ClinicalTrials.gov registry record · Phase 3
MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,783
- Enrollment target
NCT00094653: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00094653 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,783 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (131% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00094653, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,783 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.
Primary Outcome
OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
Interventions
- DRUG MDX-010 (anti-CTLA4) monoclonal antibody
- BIOLOGICAL MDX-1379 (gp100) Melanoma Peptide Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,783 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00094653 record still lists
NCT00094653 is an interventional study that assigns participants to a tested intervention. Its 1,783 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 (131% higher).
The record links to 0 conditions, and to 2 interventions - of which MDX-010 (anti-CTLA4) monoclonal antibody is the first listed.
NCT00094653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00094653 about?
NCT00094653 is a clinical study titled "MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma". The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient response...
What is the current status of trial NCT00094653?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,783 participants. The study started on 2004-09. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00094653?
The interventions under investigation include: MDX-010 (anti-CTLA4) monoclonal antibody (DRUG), MDX-1379 (gp100) Melanoma Peptide Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00094653?
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 NCT00094653's enrollment target sits among peer trials
1,783 125th of 2000 higher than 1,876 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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