Date: 2015-12-22
Type of information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: Pfizer (USA - NY) Merck KGaA (Germany)
Product: avelumab (MSB0010718C)
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor. MSB0010718C (avelumab) is a fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses and inhibits tumor growth.
Disease: ovarian cancer
Therapeutic area: Cancer - Oncology
Country: Australia, Belgium, Canada, Japan, Republic of Korea, Singapore, USA
Trial
details: This Phase 3 global study is comparing avelumab alone to avelumab plus pegylated liposomal doxorubicin and to pegylated liposomal doxorubicin alone to demonstrate that avelumab given alone or in combination with pegylated liposomal doxorubicin is superior to pegylated liposomal doxorubicin alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer. (NCT02580058)
Latest
news: * On December 22, 2015, Merck KGaA and Pfizer announced the opening of trial sites for an international Phase III study of avelumab in patients with platinum-resistant/refractory ovarian cancer. The JAVELIN Ovarian 200 trial is the first Phase III study of a PD-L1 inhibitor investigated as a treatment for platinum-resistant/refractory ovarian cancer. The first trial sites are expected to open shortly. This Phase III, randomized (1:1:1), open-label, parallel, multicenter, global study (JAVELIN Ovarian 200) is designed to evaluate the superiority of avelumab as a monotherapy or in combination with pegylated liposomal doxorubicin (PLD), compared with PLD alone, in treating patients with platinum-resistant/refractory ovarian cancer. The primary endpoint is overall survival (OS). Study investigators anticipate enrolling approximately 550 patients across more than 190 sites in Asia, Europe and North America.
The clinical development program for avelumab now includes more than 1,500 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer,
melanoma, Merkel cell carcinoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (e.g. bladder) cancer. The alliance has initiated six pivotal trials, reaching its goal for 2015, with additional trials expected to initiate in 2016.
