Merck KGaA, Pfizer Advance Phase 3 Trials of Avelumab

German drugmaker Merck KGaA and Pfizer are moving ahead with a Phase 3 study of the immunotherapy agent avelumab as a maintenance treatment for patients with bladder cancer.

The FDA gave the o.k. to advance the trial for maintenance treatment in the first line setting for patients with locally advanced or metastatic urothelial cancer. It will assess treatment with avelumab plus best supportive care versus BSC alone in roughly 670 patients.

The companies expect to open trial sites soon for avelumab for treatment of patients with platinum-resistant/refractory ovarian cancer.