NCT06486441进行中（未招募）3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 640
- 试验地点
- 311
- 主要终点
- Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC).
The primary objectives of this study are to evaluate the effect of SG compared to TPC on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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 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.
研究组 & 干预措施
Sacituzumab Govitecan (SG)
Experimental
Participants will receive SG at a dose of 10 mg/kg on Days 1 and 8 of a 21-day cycle.
干预措施: Sacituzumab govitecan-hziy (Drug)
Treatment of Physician's Choice (TPC)
Active Comparator
Participants will receive one of the following TPC, regimens determined prior to randomization.
- Doxorubicin 60 mg/m^2 IV on Day 1 of a 21-day cycle
- Paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of a 28-day cycle
干预措施: Doxorubicin (Drug)
Treatment of Physician's Choice (TPC)
Active Comparator
Participants will receive one of the following TPC, regimens determined prior to randomization.
- Doxorubicin 60 mg/m^2 IV on Day 1 of a 21-day cycle
- Paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of a 28-day cycle
干预措施: Paclitaxel (Drug)
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 Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever comes first.
Overall Survival (OS)
时间窗: Up to approximately 47 months
Overall survival (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(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 16(Baseline, Week 16)
- PFS as Assessed by Investigator(Up to approximately 27 months)
- ORR as Assessed by Investigator(Up to approximately 47 months)
- 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)
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)(First dose date up to 30 days post last dose (Up to Up to approximately 47 months))
- Percentage of Participants Experiencing Clinical Laboratory Abnormalities(First dose date up to 30 days post last dose (Up to Up to approximately 47 months))
- Change from baseline in Global Health Status (GHS)/Quality of Life (QoL) 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 16(Baseline, Week 16)
- Objective Response Rate (ORR) as Assessed by BICR(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 16(Baseline, Week 16)
- PFS as Assessed by Investigator(Up to approximately 27 months)
- ORR as Assessed by Investigator(Up to approximately 47 months)
- 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)
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)(First dose date up to 30 days post last dose (Up to Up to approximately 47 months))
- Percentage of Participants Experiencing Clinical Laboratory Abnormalities(First dose date up to 30 days post last dose (Up to Up to approximately 47 months))
- Change from baseline in Global Health Status (GHS)/Quality of Life (QoL) 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 16(Baseline, Week 16)
研究者
研究点 (311)
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