背景:晚期/复发性子宫内膜癌患者预后差,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,以改善和个性化治疗,从而影响患者的预后。在ENGOT-EN5/GOG-3055/SIENDOIII期研究的探索性分析中,selinexor维持单药80mg治疗晚期/复发性子宫内膜癌,预先指定的TP53野生型(wt)子宫内膜癌患者亚组在长期随访中显示出初步的活性,安全性通常是可控的(中位无进展生存期27.4个月vs安慰剂5.2个月,HR=0.41)。
目的:评估selinexor与安慰剂相比作为晚期或复发性TP53wt子宫内膜癌患者维持治疗的疗效。
目的:Selinexor作为维持治疗,在TP53wt晚期/复发性子宫内膜癌患者中,与安慰剂相比,每周60mg的维持治疗将显示出可控的安全性和维持疗效。
方法:这是一个前瞻性的,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TP53wt子宫内膜癌患者维持治疗的有效性和安全性。
■符合条件的患者必须有组织学确诊的子宫内膜癌,TP53wt通过下一代测序确认,完成至少12周的铂类治疗,有或没有免疫治疗,确认部分反应或完全反应,和原发性IV期疾病或首次复发。
方法:主要终点是研究人员评估的意图治疗人群中实体瘤的无进展生存期评估标准(RECIST)v1.1。
方法:共纳入220名患者。
■应计项目预计将于2024年完成,并在2025年提交结果。
背景:NCT05611931。
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).
OBJECTIVE: To evaluate the efficacy of selinexor compared with placebo as maintenance therapy in patients with advanced or recurrent TP53wt endometrial cancer.
OBJECTIVE: Selinexor administered at 60 mg weekly as maintenance therapy will show manageable safety and maintain efficacy in patients with TP53wt advanced/recurrent endometrial cancer after systemic therapy versus placebo.
METHODS: 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 TP53wt endometrial cancer.
UNASSIGNED: Eligible patients must have histologically confirmed endometrial cancer, TP53wt 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.
METHODS: 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.
METHODS: A total of 220 patients will be enrolled.
UNASSIGNED: Accrual is expected to be completed in 2024 with presentation of results in 2025.
BACKGROUND: NCT05611931.