Cancer Clinical Trial
Official title:
Phase II 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 objective clinical responses of patients in both treatment
groups: complete response and partial response.
Eligible participants will be randomized to receive either a vaccine treatment consisting of a series of multi-antigen melanoma vaccine and GM-CSF injections, followed by high-dose IFN-α2b or only the high-dose IFN-α2b. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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