铂抗性/难治性卵巢癌患者的治疗选择有限且效果较差。开发新颖、更有效的疗法可以满足重要的未满足医疗需求。奥尔维乐基因纳米病毒溶瘤免疫疗法（Olvi-Vec）在肿瘤微环境中具有强大的免疫调节效应，可能在铂抗性/难治性卵巢癌中重新敏感化铂并在临床上逆转铂抗性或难治性。该研究的主要目标是评估腹腔内Olvi-Vec联合铂类化疗和贝伐单抗治疗铂抗性/难治性卵巢癌的疗效。该三期研究调查奥尔维乐基因纳米病毒溶瘤免疫疗法后联合铂类化疗和贝伐单抗作为免疫化疗，评估这种序贯联合疗法与铂类化疗和贝伐单抗治疗相比能够延长无进展生存期（PFS）并带来其他临床益处的假设。这是一项多中心、前瞻性、随机、以活性药物对照的三期试验。患者将以2比1的比例随机分配到实验组（使用Olvi-Vec治疗后接受铂双t化疗和贝伐单抗）或对照组（接受铂双t化疗和贝伐单抗）进行治疗。符合条件的患者必须患有复发的、铂抗性/难治性的、不可手术的高级别浆液性、子宫内膜样或透明细胞卵巢、输卵管或原发性腹膜癌。患者需接受≥3线化疗方可符合入选条件。主要终点是意图治疗人群中的PFS。计划招募约186名患者（约124名患者随机分配至实验组，62名患者分配至对照组），以捕获至少127个PFS事件。预计2024年完全招募患者，并于2025年展示主要终点结果。NCT05281471.© 2023 IGCS and ESGO。不得进行商业再利用。由BMJ出版。

Treatment options for patients with platinum-resistant/refractory ovarian cancers are limited and only marginally effective. The development of novel, more effective therapies addresses a critical unmet medical need. Olvimulogene nanivacirepvec (Olvi-Vec), with its strong immune modulating effect on the tumor microenvironment, may provide re-sensitization to platinum and clinically reverse platinum resistance or refractoriness in platinum-resistant/refractory ovarian cancer.The primary objective is to evaluate the efficacy of intra-peritoneal Olvi-Vec followed by platinum-based chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer.This phase III study investigates Olvi-Vec oncolytic immunotherapy followed by platinum-based chemotherapy and bevacizumab as an immunochemotherapy evaluating the hypothesis that such sequential combination therapy will prolong progression-free survival (PFS) and bring other clinical benefits compared with treatment with platinum-based chemotherapy and bevacizumab.This is a multicenter, prospective, randomized, and active-controlled phase III trial. Patients will be randomized 2:1 into the experimental arm treated with Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab or the control arm treated with platinum-doublet chemotherapy and bevacizumab.Eligible patients must have recurrent, platinum-resistant/refractory, non-resectable high-grade serous, endometrioid, or clear-cell ovarian, fallopian tube, or primary peritoneal cancer. Patients must have had ≥3 lines of prior chemotherapy.The primary endpoint is PFS in the intention-to-treat population.Approximately 186 patients (approximately 124 patients randomized to the experimental arm and 62 to the control arm) will be enrolled to capture 127 PFS events.Expected complete accrual in 2024 with presentation of primary endpoint results in 2025.NCT05281471.© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.