Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
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.
Timeline
- Start
- 2008-06
- Primary completion
- 2010-04
- Completion
- 2010-06
Outcome
Missed primary endpoint
Stopped (Enrollment): “No safety concerns, the study was terminated due to slow enrollment. All enrolled patients were followed per protocol.”
registry analysis (superiority or other test); Study Group 1: ALVAC Melanoma Vaccine vs Study Group 2: Interferon Alpha-2b; p = 0.9406; Log Rank NCT00613509 ↗
registry analysis (superiority or other test); Study Group 1: ALVAC Melanoma Vaccine vs Study Group 2: Interferon Alpha-2b; p = 0.9179; Likelihood ratio test NCT00613509 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALVAC(2) | Vaccine | 0.5 ml | — |
| Comparator | interferon alfa-2b | Protein / enzyme biologic | 0.5 ml | — |