Background Patients with advanced/recurrent endometrial cancer have a poor prognosis and limited treatment options. Biomarkers such as tumor protein 53 ( TP53 ) in endometrial cancer can integrate novel strategies for improved and individualized treatment that could impact patient outcomes. In an exploratory analysis of the phase III ENGOT-EN5/GOG-3055/SIENDO study of selinexor maintenance monotherapy 80 mg in advanced/recurrent endometrial cancer, a pre-specified subgroup of patients with TP53 wild type (wt) endometrial cancer showed preliminary activity at long-term follow-up with a generally manageable safety profile (median progression-free survival 27.4 months vs 5.2 months placebo, HR=0.41). Primary Objective To evaluate the efficacy of selinexor compared with placebo as maintenance therapy in patients with advanced or recurrent TP53 wt endometrial cancer. Study Hypothesis Selinexor administered at 60 mg weekly as maintenance therapy will show manageable safety and maintain efficacy in patients with TP53 wt advanced/recurrent endometrial cancer after systemic therapy versus placebo. Trial Design This is a prospective, multicenter, double-blind, placebo-controlled, randomized phase III study designed to evaluate the efficacy and safety of selinexor as a maintenance therapy in patients with advanced or recurrent TP53 wt endometrial cancer. Major Inclusion/Exclusion Criteria Eligible patients must have histologically confirmed endometrial cancer, TP53 wt confirmed by next-generation sequencing, completed at least 12 weeks of platinum-based therapy with or without immunotherapy, with confirmed partial response or complete response, and primary Stage IV disease or at first relapse. Primary Endpoint The primary endpoint is investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the intent-to-treat population. Sample Size A total of 220 patients will be enrolled. Estimated Dates for Completing Accrual and Presenting Results Accrual is expected to be completed in 2024 with presentation of results in 2025. Trial Registration [NCT05611931][1] There are no data in this work. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05611931&atom=%2Fijgc%2Fearly%2F2024%2F04%2F16%2Fijgc-2024-005412.atom

中文翻译：

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ENGOT-EN20/GOG-3083/XPORT-EC-042 – 一项 III 期、随机、安慰剂对照、双盲、多中心试验，selinexor 用于 p53 野生型、晚期或复发患者全身治疗后的维持治疗子宫内膜癌：基本原理、方法和试验设计

背景 晚期/复发性子宫内膜癌患者预后不良，治疗选择有限。子宫内膜癌中的肿瘤蛋白 53 (TP53) 等生物标志物可以整合新策略来改进和个体化治疗，从而影响患者的治疗结果。在对 80 mg selinexor 维持单药治疗晚期/复发性子宫内膜癌的 III 期 ENGOT-EN5/GOG-3055/SIENDO 研究的探索性分析中，预先指定的 TP53 野生型 (wt) 子宫内膜癌患者亚组显示出初步活性在长期随访中，安全性总体可控（中位无进展生存期为 27.4 个月，安慰剂组为 5.2 个月，HR=0.41）。主要目的 评估 selinexor 与安慰剂相比作为晚期或复发性 TP53 wt 子宫内膜癌患者维持治疗的疗效。研究假设与安慰剂相比，每周 60 mg 的 Selinexor 作为维持治疗，对于 TP53 wt 晚期/复发性子宫内膜癌患者，与安慰剂相比，在全身治疗后将显示出可控的安全性并维持疗效。试验设计 这是一项前瞻性、多中心、双盲、安慰剂对照、随机 III 期研究，旨在评估 selinexor 作为晚期或复发性 TP53 wt 子宫内膜癌患者维持治疗的有效性和安全性。主要纳入/排除标准 符合资格的患者必须患有组织学证实的子宫内膜癌、通过下一代测序证实的 TP53 wt、完成至少 12 周的铂类治疗（联合或不联合免疫治疗）、确认部分缓解或完全缓解以及初级 IV 期疾病或首次复发。主要终点 主要终点是研究者根据实体瘤疗效评估标准 (RECIST) v1.1 在意向治疗人群中评估的无进展生存期。样本量 总共将招募 220 名患者。完成应计和提交结果的预计日期 应计预计将于 2024 年完成，并于 2025 年提交结果。 试验注册 [NCT05611931][1] 这项工作中没有数据。 [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05611931&atom=%2Fijgc%2Fearly%2F2024%2F04%2F16%2Fijgc-2024-005412.atom