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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 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,783 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00094653
The ClinicalTrials.gov registry entry for NCT00094653 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,783 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MDX-010 (anti-CTLA4) monoclonal antibody is the first listed.
NCT00094653 reports 0 study locations.
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.
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