Polynoma LLC announced the start of MAVIS, the company’s Phase 3 trial of POL 103A vaccine for melanoma.
MAVIS (Melanoma Antigen Vaccine Immunotherapy Study), a global, multi-center, double-blind, placebo-controlled study enrolled 1,059 patients with resected Stage IIb, IIc or III melanoma. This study will consist of two stages, the first being a lead-in stage (n=99) designed to assess vaccine safety and bioactivity and select the vaccine dose to be used in the second and final stage of the study. The second stage (n=960) is designed to assess the efficacy of POL 103A by randomizing patients to POL 103A or a placebo vaccine on a 2:1 basis.
This Phase 3 study has been initiated based on results of two randomized, placebo-controlled Phase 2 trials that demonstrated strong efficacy in terms of significantly improved recurrence-free survival (RFS), overall survival (OS), and a favorable safety profile.
POL 103A is a novel vaccine designed to stimulate the body’s immune system to fight cancer using a combination of shed antigens produced by three proprietary melanoma cell lines. Antigens are rapidly released from the cancer cells, then purified and processed prior to administration to patients.
For more information call (858) 205-2501or visit www.polynoma.com.