MabVax Therapeutics announced the enrollment of the first patients for its Phase 2 study to assess the efficacy and safety of its vaccine to prevent or delay the recurrence of sarcoma. This clinical trial will enroll 126 metastatic sarcoma patients, ≥16 years of age, in a randomized, multicenter, double-blind study of a trivalent vaccine specifically developed to target and kill residual circulating cancer cells and micrometastases thought to cause recurrent cancer. The primary objective is to determine the 1-year Progression Free Survival Rate in patients with metastatic sarcoma who are without evidence of disease and who are treated with the vaccine plus adjuvant or with the adjuvant alone. Secondary objectives are to determine Overall Survival, Disease Free Survival, and Disease Specific Survival, along with Progression Free Survival at the 3-year time point.
The vaccine is a trivalent ganglioside vaccine intended to instruct the patient’s immune system to make antibodies against the three ganglioside antigens present on the surface of sarcoma cells. The antibodies will then seek out and kill the residual circulating cancer cells and micrometastases with the objective of preventing disease recurrence.
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