A Randomized, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of avelumab in Combination with Chemotherapy followed by maintenance therapy of avelumab in combination with The Poly (Adenosine Diphosphate [ADP]-RIBOSE) Polymerase (PARP) Inhibitor Talazoparib in patients with previously untreated advanced ovarian cancer (JAVELIN OVARIAN PARP 100)
Johns Hopkins Kimmel Cancer Center in Baltimore
This study will see if adding the study drug, avelumab, to frontline chemotherapy followed by avelumab and talazoparib as maintenance regimen, is better at delaying advancement of ovarian cancer than chemotherapy and bevacizumab, followed by bevacizumab maintenance treatment.
Patients with histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including carcinosarcoma with high-grade serous component. Patients must be candidates for bevacizumab in combination with platinum based chemotherapy and previously untreated. Patients must have completed a primary surgical debulking procedure, or be candidates for neoadjuvant chemotherapy with planned interval debulking surgery. Availability of an archival biopsy tissue or a fresh tumor sample must be obtained during screening. Exclusions include prior exposure to immunotherapy, PARP inhibitor, bevacizumab, targeted therapy or hormonal therapy for their ovarian, peritoneal primary or fallopian tube cancer, and radiotherapy to any portion of the abdominal cavity or pelvis.
The study period includes two treatment periods, the chemotherapy period and the maintenance period. During the chemotherapy period, eligible patients will be randomized to 1 of 3 arms: Arm A) Chemotherapy + Avelumab; Arm B) Chemotherapy; Arm C) Chemotherapy + Bevacizumab. All of these study drugs are administered intravenously. During the maintenance period, study drug will be assigned and given as follows: Arm A) Avelumab (intravenously) + Talazoparib (orally); Arm B) Talazoparib (orally); Arm C) Bevacizumab (intravenously). Patients will receive study treatment until progressive disease per RECIST v1.1, unacceptable toxicity, or patient withdrawal.
03/05/2019 05:03 AM