Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer Clinical Trial
Official title:
A Single-arm Phase II Study of Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer (OPEB-01)
This study is phase II, open label, clinical trial to determine the efficacy of Olaparib maintenance with Bevacizumab and Pembrolizumab by assessment progression-free survival(6 months PFS rate) in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer.
'This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of Olaparib maintenance with Bevacizumab and Pembrolizumab in subjects with platinum-sensitive who have received prior of platinum-based chemotherapy. The study will assess the effectiveness of progression-free survival(6 months PFS rate) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The subject will be treated to until disease progression as below: - Maintenance : Olaparib 300mg (twice daily [BID]) - Pembrolizumab 200mg every 3 weeks (Q3W) from 2nd infusion for up to 35 infusions - Bevacizumab 15mg/kg or 7.5mg/kg every 3 weeks (Q3W) ;