OPERA: a phase II trial of oregovomab plus non-platinum chemotherapy in PARP inhibitor/platinum-resistant ovarian cancer.

IF 3 4区医学 Q2 ONCOLOGY Future oncology Pub Date : 2024-01-01 Epub Date: 2024-06-28 DOI:10.1080/14796694.2024.2357533

Junsik Park, Hyun Woong Cho, Myong Cheol Lim, Chel Hun Choi, Jung-Yun Lee

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Abstract

A consensus regarding subsequent therapeutic strategies for patients with platinum- and poly (ADP-ribose) polymerase inhibitor (PARPi)-resistant ovarian cancer is lacking. These patients typically receive non-platinum-based chemotherapy; however, survival outcomes remain poor. Compared with chemotherapy alone, combination therapy with novel target agents can provide additional benefits to these patients. Oregovomab, an investigational murine monoclonal antibody against CA-125, has shown promising efficacy in a phase II study in patients with recurrent ovarian cancer. Herein, we described the rationale and design of OPERA/KGOG 3065/APGOT-OV6, a multicenter, investigator-initiated, two-cohort, single-arm phase II trial, aimed at examining the efficacy of oregovomab plus non-platinum-based chemotherapy in patients with PARPi/platinum-resistant ovarian cancer. The primary end point was the objective response rate, according to RECIST 1.1.Clinical Trial Registration: NCT05407584 (ClinicalTrials.gov).

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OPERA：PARP抑制剂/铂类耐药卵巢癌奥列戈单抗加非铂类化疗的II期试验。

对于铂类和多聚（ADP-核糖）聚合酶抑制剂（PARPi）耐药卵巢癌患者的后续治疗策略，目前还缺乏共识。这些患者通常接受非铂类化疗，但生存率仍然很低。与单独化疗相比，与新型靶向药物联合治疗可为这些患者带来更多益处。Oregovomab是一种针对CA-125的小鼠单克隆抗体，在一项针对复发性卵巢癌患者的II期研究中显示出良好的疗效。在此，我们介绍了 OPERA/KGOG 3065/APGOT-OV6 的原理和设计，这是一项由研究者发起的多中心、双队列、单臂 II 期试验，旨在考察奥列戈单抗联合非铂类化疗对 PARPi/铂类耐药卵巢癌患者的疗效。根据 RECIST 1.1 标准，主要终点是客观反应率：临床试验注册：NCT05407584（ClinicalTrials.gov）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Future oncology ONCOLOGY-

CiteScore

5.40

自引率

3.00%

发文量

335

审稿时长

4-8 weeks

期刊介绍： Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.