J Gynecol Oncol.  2021 Mar;32(2):e31. 10.3802/jgo.2021.32.e31.

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)

Affiliations
  • 1Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea
  • 2Division of Tumor Immunology, Center for Gynecologic Cancer and Center for Clinical Trials, Research Institute and Hospital, National Cancer Center, Goyang, Korea
  • 3Department of Cancer Control & Population Health, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Korea
  • 4Gynecologic Cancer Branch & Center for Uterine Cancer, National Cancer Center, Goyang, Korea
  • 5Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 6Department of Haematology-Oncology, National University Cancer Institute, Singapore
  • 7Cancer Science Institute, National University of Singapore, Singapore

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.

Keyword

Ovarian Neoplasms; Bevacizumab; Poly(ADP-ribose) Polymerase Inhibitors; Immunotherapy Recurrence
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