A single-arm phase II study of olaparib maintenance with pembrolizumab and bevacizumab in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer (OPEB-01)
- Author:
Yong Jae LEE
1
;
Myong Cheol LIM
;
Byoung-Gie KIM
;
Natalie YL NGOI
;
Chel Hun CHOI
;
Sang-Yoon PARK
;
David SP TAN
;
Yunjung GO
;
Jung-Yun LEE
Author Information
- Publication Type:Clinical Trial Protocol
- From:Journal of Gynecologic Oncology 2021;32(2):e31-
- CountryRepublic of Korea
- Language:English
-
Abstract:
Background:The optimal treatment of BRCA wild-type patients with platinum-sensitive recurrent ovarian cancer remains unknown. Recently, there is an increase in the evidence to support the role of the combination of a poly(adenosine diphosphate-ribose) polymerase inhibitor, anti-angiogenic agents, and immunotherapy as maintenance therapy in BRCA wild-type patients with platinum-sensitive recurrence. We hypothesized that adding pembrolizumab and bevacizumab to olaparib maintenance can increase progression-free survival (PFS) in BRCA wild-type patients with platinum-sensitive recurrent ovarian cancer.
Methods:BRCA wild-type patients who received two previous courses of platinum-containing therapy, achieved complete or partial response to last treatment, and the treatment-free interval is >6 months after the penultimate platinum-based chemotherapy offered olaparib maintenance with pembrolizumab and bevacizumab. Forty-four patients will be included from 4 sites across Singapore and Korea. The primary endpoint of the study is 6-month PFS rate.
