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 (153)
The Cancer Institute Hospital Of JFCR
🇯🇵Tokyo, Japan
St. Luke's Hospital
🇬🇷Thessaloniki, Greece
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
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
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
Tampa General Hospital (Cancer Institute)
🇺🇸Tampa, Florida, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System
🇺🇸Savannah, Georgia, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
🇺🇸Indianapolis, Indiana, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Women's Cancer Care
🇺🇸Covington, Louisiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
M Health Fairview University of Minnesota Medical Center - East Bank Hospital
🇺🇸Minneapolis, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC)
🇺🇸Saint Louis Park, Minnesota, United States
Rutgers Cancer Institute
🇺🇸New Brunswick, New Jersey, United States
University of New Mexico Comprehensive Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Northwell Health Cancer Institute
🇺🇸Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
🇺🇸Tulsa, Oklahoma, United States
Providence Cancer Institute Franz Clinic
🇺🇸Portland, Oregon, United States
Alliance Cancer Specialists, PC
🇺🇸Horsham, Pennsylvania, United States
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Texas Oncology
🇺🇸Fort Worth, Texas, United States
Baylor College of Medicine Medical Center
🇺🇸Houston, Texas, United States
University of Virginia Comprehensive Cancer Center
🇺🇸Charlottesville, Virginia, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
Froedtert and the Medical College of Wisconsin (MCW)
🇺🇸Milwaukee, Wisconsin, United States
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Clínica de Neoplasias Litoral
🇧🇷Itajai, Brazil
McGill University Health Centre - Glen Site
🇨🇦Montreal, Canada
CIC-CHU de Québec-Université Laval- Hôpital de l'Enfant-Jésus
🇨🇦Quebec, Canada
Sunnybrook Research Institute
🇨🇦Toronto, Canada
Beijing Cancer Hospital
🇨🇳Beijing, China
The First Hospital of Jilin University
🇨🇳Changchun, China
Hunan Cancer Hospital
🇨🇳Changsha, China
West China Second Hospital of Sichuan University
🇨🇳Chengdu, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Guangxi Zhuang Autonomous Region, China
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde
🇩🇪München, Germany
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
🇨🇳Guangzhou, China
Women's Hospital School Of Medicine Zhejiang University
🇨🇳Hangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Jiangxi Maternal and Child Health Hospital
🇨🇳Nanchang, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan City, China
Tongji Hospital, Tongji Medical College of HUST
🇨🇳Wuhan, China
The First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xi'an, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Nemocnice AGEL, Nový Jičín a.s.
🇨🇿Nový Jičín, Czechia
General University Hospital in Prague
🇨🇿Prague, Czechia
University Hospital Bulovka
🇨🇿Prague, Czechia
Centre Francois Baclesse
🇫🇷Caen Cedex 5, France
Institut Paoli Calmettes
🇫🇷Marseille, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hôpital Cochin
🇫🇷Paris, France
HCL - Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
ICO - Centre René Gauducheau
🇫🇷Saint-Herblain, France
Institut de Cancerologie de Lorraine
🇫🇷Vandoeuvre Les Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Hochtaunus Kliniken Bad Homburg
🇩🇪Bad Homburg, Germany
University Hospital Essen
🇩🇪Essen, Germany
Universitätsklinikum Hamburg
🇩🇪Hamburg, Germany
Medical School Hannover
🇩🇪Hannover, Germany
University Hospital Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Aretaeion Hospital
🇬🇷Athens, Greece
General Hospital of Patras Agios Andreas
🇬🇷Patras, Greece
Hong Kong Sanatorium & Hospital
🇭🇰Happy Valley, Hong Kong
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Prince of Wales Hospital
🇭🇰New Territories, Hong Kong
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Rambam Health Care Campus
🇮🇱Haifa, Israel
Wolfson Medical Center
🇮🇱Holon, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Sheba Medical Center
🇮🇱ramat GAn, Israel
Sourasky T.A.M.C.
🇮🇱Tel Aviv-Yaffo, Israel
SOC di Oncologia Medica e Prevenzione Oncologica Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
🇮🇹Aviano, Italy
Azienda Ospedaliera Universitaria Careggi - Unita di Oncologia Ginecologica
🇮🇹Firenze, Italy
ASST Lecco - Ospedale Alessandro Manzoni
🇮🇹Lecco, Italy
Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
🇮🇹Meldola, Italy
Irccs Ospedale San Raffaele-UO Ginecologia
🇮🇹Milan, Italy
Istituto Europeo di Oncologia
🇮🇹Milan, Italy
Azienda Ospedaliero Universitaria Pisana, Ospedale Santa Chiara
🇮🇹Pisa, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
🇮🇹Roma, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
🇮🇹Rome, Italy
A.O. Ordine Mauriziano di Torino
🇮🇹Torino, Italy
Chiba Cancer Center
🇯🇵Chiba, Japan
The Jikei University Kashiwa Hospital
🇯🇵Chiba, Japan
Hyogo Cancer Center
🇯🇵Hyogo, Japan
St. Marianna University Hospital
🇯🇵Kanagawa, Japan
Mie University Hospital
🇯🇵Mie, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Saitama Medical University International Medical Center
🇯🇵Saitama, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
Keimyung University Dongsan Medical Center
🇰🇷Dalseo-gu, Korea, Republic of
National Cancer Center - Korea
🇰🇷Goyang-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Szpitale Pomorskie Sp. z o.o.
🇵🇱Gdynia, Poland
Uniwersyteckie Centrum Kliniczne SUM
🇵🇱Katowice, Poland
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
🇵🇱Siedlce, Poland
National University Hospital
🇸🇬Singapore, Singapore
Complexo Hospitalario Universitario A Coruna
🇪🇸A Coruña, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Ciudad de Jaen
🇪🇸Jaén, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitari Son Espases
🇪🇸Palma, Spain
Hospital Parc Taulí
🇪🇸Sabadell, Spain
Hospital Universitario La Fe - Valencia
🇪🇸Valencia, Spain
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
🇨🇳Taoyuan City, Taiwan
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
University College London Hospitals
🇬🇧London, United Kingdom
East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre
🇬🇧Northwood, United Kingdom