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NCT00613509 · ClinicalTrials.gov registry record · Phase 2
Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT00613509: Clinical Trial Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00613509 is a Phase 2 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00613509, a Phase 2 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
Primary objective: To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment. Secondary objectives: Safety: To describe the safety profile in both treatment groups. Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response.
Primary Outcome
Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography \[CT\] scans or physical examination).
Interventions
- BIOLOGICAL ALVAC(2) Melanoma multi-antigen therapeutic vaccine
- BIOLOGICAL Intron A, Interferon alpha -2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
Why NCT00613509 stopped before completion
NCT00613509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which ALVAC(2) Melanoma multi-antigen therapeutic vaccine is the first listed.
NCT00613509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00613509 about?
NCT00613509 is a clinical study titled "Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma". Primary objective: To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment. Secondary objectives: Safety: To describe the safety profile in both treatment groups. Efficacy: To determine the object...
What is the current status of trial NCT00613509?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2008-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00613509?
The interventions under investigation include: ALVAC(2) Melanoma multi-antigen therapeutic vaccine (BIOLOGICAL), Intron A, Interferon alpha -2b (BIOLOGICAL).
Who is sponsoring clinical trial NCT00613509?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00613509's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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