PHILADELPHIA, Nov. 29 (UPI) -- U.S. firm AVAX Technologies said Wednesday it is cleared to launch a phase 3 study of its metastatic melanoma vaccine, M-Vax.
The trial will enroll as many as 387 patients with stage IV melanoma at sites in the United States, Europe and Australia. Patients will be randomized in a 2-1 ratio to receive either M-Vax or placebo.
The study will measure best overall anti-tumor response rate and the percentage of patients surviving two years, AVAX said.
The trial will also assess overall survival time, response duration, percentage of complete and partial responses, progression-free survival and treatment-related adverse events.
AVAX said the Food and Drug Administration has granted the new treatment accelerated approval, meaning the agency will review the data and make its approval decision within six months.
source - UPI