奥拉帕利维持治疗联合帕博利珠单抗和贝伐珠单抗治疗非突变型铂敏感复发性卵巢癌患者的单臂 II 期研究（OPEB-01）。
A single-arm phase II study of olaparib maintenance with pembrolizumab and bevacizumab in non-mutated patients with platinum-sensitive recurrent ovarian cancer (OPEB-01).
机构信息
Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.
Division of Tumor Immunology, Center for Gynecologic Cancer and Center for Clinical Trials, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
出版信息
J Gynecol Oncol. 2021 Mar;32(2):e31. doi: 10.3802/jgo.2021.32.e31. Epub 2021 Jan 27.
BACKGROUND
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.
METHODS
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.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04361370, Clinical Research Information Service Identifier: KCT0005144.
背景
铂类敏感复发性卵巢癌野生型患者的最佳治疗方法仍不清楚。最近，越来越多的证据支持将聚（二磷酸腺苷核糖）聚合酶抑制剂、抗血管生成药物和免疫疗法联合作为铂类敏感复发性野生型患者的维持治疗。我们假设在奥拉帕利维持治疗中加入帕博利珠单抗和贝伐珠单抗可以提高铂类敏感复发性卵巢癌野生型患者的无进展生存期（PFS）。
方法
在新加坡和韩国的 4 个地点，我们将纳入 44 名接受过两次铂类药物治疗、末次治疗达到完全或部分缓解、末次铂类化疗后无治疗间隔>6 个月的野生型患者，给予奥拉帕利维持治疗联合帕博利珠单抗和贝伐珠单抗。该研究的主要终点是 6 个月的 PFS 率。
试验注册
ClinicalTrials.gov 标识符：NCT04361370，Clinical Research Information Service 标识符：KCT0005144。
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