Under the Javelin Ovarian 200 open-label, parallel group, global study, the companies will assess the superiority of avelumab as monotherapy or in combination with pegylated liposomal doxorubicin (PLD) compared to PLD alone in patients with platinum-resistant/refractory ovarian cancer.
Overall survival (OS) is the primary endpoint of the study, which will be carried out on about 550 patients in more than 190 sites in Europe, Asia and North America.
The Javelin Bladder 100 global study will assess avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer. Avelumab and best supportive care (BSC) will be compared to BSC alone.
OS is also the primary endpoint of the study, which is anticipated to enroll 668 patients across more than 200 sites in 38 countries.
Merck biopharma business head of global clinical development Alise Reicin said: "Locally advanced or metastatic urothelial cancer is another aggressive cancer, with the disease often progressing quickly following first-line treatment.
"It’s an exciting time for the Merck-Pfizer Alliance as we continue to accelerate our clinical development program, and now into urothelial cancer. This disease has an exceptionally high unmet need and we believe there is potential for our anti-PD-L1 antibody to be part of future treatment strategies."
Avelumab, also known as MSB0010718C, inhibits PD-L1 interactions to potentially allow the activation of T-cells and the adaptive immune system.
Other studies of avelumab are ongoing in breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, melanoma, Merkel cell carcinoma, non-small cell lung cancer, and renal cell carcinoma.
Image: Avelumab inhibits PD-L1 interactions to potentially allow the activation of T-cells and the adaptive immune system. Photo: courtesy of Merck KGaA, Darmstadt, Germany.