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ACTIVE NOT RECRUITING
NCT06486441
PHASE3

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

View on ClinicalTrials.gov

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

2026-01-15

Healthy Volunteers

No

Interventions

DRUG

Sacituzumab govitecan-hziy

Administered intravenously

DRUG

Doxorubicin

Administered intravenously

DRUG

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

Centre Francois Baclesse

Caen, France

Institut Paoli Calmettes

Marseille, France

Centre Antoine Lacassagne

Nice, France

Hôpital Cochin

Paris, France

HCL - Centre Hospitalier Lyon Sud

Pierre-Bénite, France

ICO - Centre René Gauducheau

Saint-Herblain, France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy

Villejuif, France

Hochtaunus Kliniken Bad Homburg

Bad Homburg, Germany

Universitatsklinikum Dusseldorf

Düsseldorf, Germany

University Hospital Essen

Essen, Germany

Universitätsklinikum Hamburg

Hamburg, Germany

Medical School Hannover

Hanover, Germany

University Hospital Leipzig

Leipzig, Germany

Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde

München, Germany

Universitätsklinikum Ulm

Ulm, Germany

Aretaeion Hospital

Athens, Greece

MITERA hospital

Athens, Greece

Kalamata Hospital

Kalamata, Greece

General Hospital of Patras Agios Andreas

Pátrai, Greece

St. Luke's Hospital

Thessaloniki, 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, 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

Florence, 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

Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Istituto Oncologico Veneto IRCCS

Padova, 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

AOU Città della Salute e della Scienza di Torino - Presidio Sant'Anna

Torino, Italy

A.O. Ordine Mauriziano di Torino

Torino, Italy

Chiba Cancer Center

Chiba, Japan

The Jikei University Kashiwa Hospital

Chiba, Japan

Hyogo Cancer Center

Hyōgo, 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

The Cancer Institute Hospital Of JFCR

Tokyo, Japan

Szpitale Pomorskie Sp. z o.o.

Gdynia, Poland

Uniwersyteckie Centrum Kliniczne SUM

Katowice, Poland

Oddział Ginekologii Onkologicznej Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach

Siedlce, Poland

Dolnoslaskie Centrum Onkologii

Wroclaw, Poland

National University Hospital

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

Keimyung University Dongsan Medical Center

Dalseo-gu, South Korea

National Cancer Center - Korea

Goyang-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital

Seoul, South Korea

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 Donostia

San Sebastián, Spain

Hospital Universitario La Fe - Valencia

Valencia, Spain

Kaohsiung Veterans General Hospital

Kaohsiung City, 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, Taiwan

Birmingham Heartlands Hospital

Birmingham, United Kingdom

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