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Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)
Sponsor: Gilead Sciences
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).
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
640
Start Date
2024-08-28
Completion Date
2029-06
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab govitecan-hziy
Administered intravenously
Doxorubicin
Administered intravenously
Paclitaxel
Administered intravenously
Locations (189)
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
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, 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
Baptist MD Anderson Cancer Center
Jacksonville, 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
Northwestern Memorial Hospital
Chicago, Illinois, 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
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
University of Mississippi Medical Center
Jackson, Mississippi, United States
MidAmerica Division, Inc. c/o Research Medical Center
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 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
Columbia University Medical Center, Herbert Irving Pavilion
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, 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
MUSC Hollings Cancer Center
Charleston, South Carolina, 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
The University of Texas MD Anderson Cancer 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
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Mater Cancer Care Centre
South Brisbane, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Murdoch, Western Australia, Australia
Clínica de Neoplasias Litoral
Itajaí, Brazil
Centro de Pesquisa Clínica do Hospital Moinhos de Vento
Porto Alegre, Brazil
Hospital Santa Joana Recife
Recife, Brazil
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro, Brazil
Ensino e Terapia de Inovação Clínica AMO - ETICA
Salvador, Brazil
Instituto do Câncer do Estado de São Paulo
São Paulo, Brazil
BP - A Beneficência Portuguesa da São Paulo / Hospital BP Mirante
São Paulo, Brazil
DASA - Hospital 9 de Julho
São Paulo, Brazil
AC Camargo Cancer Center (Fundação Antonio Prudente)
São Paulo, Brazil
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Canada
London Health Sciences Centre
London, Canada
McGill University Health Centre - Glen Site
Montreal, Canada
CIC-CHU de Québec-Université Laval- Hôpital de l'Enfant-Jésus
Québec, Canada
Sunnybrook Research Institute
Toronto, Canada
Princess Margaret Cancer Centre
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
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
Harbin Medical University Cancer Hospital
Harbin, 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, 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
University Hospital Ostrava
Ostrava-Poruba, Czechia
General University Hospital in Prague
Prague, Czechia
University Hospital Bulovka
Prague, Czechia