Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy
- Conditions
- Endometrial Cancer
- Interventions
- Registration Number
- NCT06486441
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 520
- 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 v1.1.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Adequate organ function
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment of Physician's Choice (TPC) Doxorubicin 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 Sacituzumab Govitecan (SG) Sacituzumab govitecan-hziy Participants will receive SG at a dose of 10 mg/kg on Days 1 and 8 of a 21-day cycle. Treatment of Physician's Choice (TPC) Paclitaxel 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
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) 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) Up to approximately 47 months Overall survival (OS) is defined as time from the date of randomization until death due to any cause.
- Secondary Outcome Measures
Name Time Method 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 The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. The physical functioning scale range in score from 0 to 100. Higher score denote a better level of functioning (i.e. a better state of the participant).
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 13 Baseline, Week 13 The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. Global health status score ranges from 0 to 100. Higher score denote a better level of functioning (i.e. a better state of the participant).
ORR as Assessed by Investigator Up to approximately 47 months ORR is defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by investigator per RECIST v1.1
Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator Up to approximately 47 months CBR is defined as the percentage of participants with best overall response of CR or PR that is confirmed ≥ 4 weeks after initial documentation of response or durable stable disease (SD; duration of SD ≥ 6 months from randomization to disease progression), as assessed by BICR and investigator per RECIST v1.1.
Objective Response Rate (ORR) as Assessed by BICR Up to approximately 47 months ORR, defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by BICR per RECIST v1.1.
PFS as Assessed by Investigator Up to approximately 27 months PFS is defined as the time from the date of randomization until the date of objective PD, as assessed by investigator per RECIST v1.1, or death from any cause, whichever comes first
Duration of Response (DOR) as Assessed by BICR and Investigator Up to approximately 47 months DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD as assessed by BICR and investigator per RECIST v1.1, or death from any cause, whichever comes first.
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)
Trial Locations
- Locations (171)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
City of Hope
🇺🇸Duarte, California, United States
UC San Diego Medical Center
🇺🇸La Jolla, California, United States
Stanford Women's Cancer Center
🇺🇸Palo Alto, California, United States
Kaiser Permanente Medical Center
🇺🇸Vallejo, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
🇺🇸Aurora, Colorado, United States
Hartford HealthCare Cancer Institute at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Scroll for more (161 remaining)University of Arkansas for Medical Sciences🇺🇸Little Rock, Arkansas, United States