A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Gilead Sciences, K.K.0 个研究点目标入组 520 人开始时间: 待定最近更新: 2024年12月12日

试验速览

阶段: 不适用
状态: 招募中
发起方: Gilead Sciences, K.K.
入组人数: 520
主要终点: Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old exceed 至 No limit（—）
性别: Female

入选标准

•Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma).
•Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately.
•Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator.
•Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
•Eastern Cooperative Oncology Group performance status score of 0 or
•Adequate organ function.

排除标准

•Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded.
•Participants who are candidates for curative-intent therapy at the time of study enrollment.
•Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator.
•Received any prior treatment with a Trop-2-directed antibody-drug conjugate (ADC).
•Have an active second malignancy.
•Have an active serious infection requiring systemic antimicrobial therapy.
•Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months prior to randomization.
•Have a positive serum pregnancy test or are breastfeeding for participants who are assigned female at birth.
•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

结局指标

主要结局

Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR)

时间窗: Up to approximately 27 months

PFS, defined as the time from the date of randomization until the date of objective progressive disease (PD), as assessed by BICR per RECIST v1.1, or death from any cause, whichever comes first.

Overall Survival (OS)

时间窗: Up to approximately 47 months

OS is defined as time from the date of randomization until death due to any cause.

次要结局

Objective Response Rate (ORR) as Assessed by BICR and Investigator(Up to approximately 47 months)
Change from Baseline in the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 13(Baseline, Week 13)
Duration of Response (DOR) as Assessed by BICR and Investigator(Up to approximately 47 months)
Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator(Up to approximately 47 months)
Change from baseline in Global Health Status (GHS)/Quality of Life (QoL) Domain of the EORTC QLQ-C30 at Week 13(Baseline, Week 13)

研究者

发起方

Gilead Sciences, K.K.

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