The special protocol assessment (SPA) specifies the trial objectives and design, clinical endpoints, and planned analyses that would be needed to apply for product approval.
The phase III, open-label, multi-center trial calls for enrollment of approximately 375 patients with recurrent metastatic melanoma. Patients may have been treated with surgery, adjuvant therapy, and/or biotherapy, but not chemotherapy.
The patients will be randomized on a 2:1 basis: approximately 250 patients will be treated with Allovectin-7 and around 125 will be treated with either of two chemotherapy agents, dacarbazine (Bayer’s DTIC-Dome) or temozolomide (Schering-Plough’s Temodar). The primary endpoint is a comparison of objective response rates at 24 weeks or more after randomization. The study will also evaluate safety and tolerability.
“We are pleased to have reached an agreement with the FDA for a feasible trial design featuring achievable endpoints and providing a clear path to approval,” said Vijay Samant, Vical’s president and CEO. “Now we can advance in our discussions with potential partners and evaluate which, if any, is best positioned to assist with the further development and commercialization of Allovectin-7.”