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)

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)

The optimal treatment of 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...

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Published in:Journal of gynecologic oncology Vol. 32; no. 2; p. e31
Main Authors: Lee, Yong Jae, Lim, Myong Cheol, Kim, Byoung Gie, Ngoi, Natalie Yl, Choi, Chel Hun, Park, Sang Yoon, Tan, David Sp, Go, Yunjung, Lee, Jung Yun
Format: Journal Article
Language:English
Published: Korea (South) Asian Society of Gynecologic Oncology; Korean Society of Gynecologic Oncology; Japan Society of Gynecologic Oncology 01-03-2021
대한부인종양학회
Subjects:
Clinical Trial Protocol
산부인과학
Immunotherapy Recurrence
Ovarian Neoplasms
Poly(ADP-ribose) Polymerase Inhibitors
Bevacizumab
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Summary:The optimal treatment of 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 wild-type patients with platinum-sensitive recurrence. We hypothesized that adding pembrolizumab and bevacizumab to olaparib maintenance can increase progression-free survival (PFS) in wild-type patients with platinum-sensitive recurrent ovarian cancer. 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. ClinicalTrials.gov Identifier: NCT04361370, Clinical Research Information Service Identifier: KCT0005144.
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https://doi.org/10.3802/jgo.2021.32.e31
ISSN:2005-0380
2005-0399
DOI:10.3802/jgo.2021.32.e31