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
Status: Recruiting
Location: See all (187) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
California
City of Hope
RECRUITING
Duarte
UC San Diego Medical Center
RECRUITING
La Jolla
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Stanford Women's Cancer Center
RECRUITING
Palo Alto
Kaiser Permanente Medical Center
RECRUITING
Vallejo
Colorado
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
RECRUITING
Aurora
Connecticut
Hartford HealthCare Cancer Institute at Hartford Hospital
RECRUITING
Hartford
Yale University School of Medicine
RECRUITING
New Haven
Florida
Florida Cancer Specialists
RECRUITING
Fort Myers
University of Florida
RECRUITING
Gainesville
Baptist MD Anderson Cancer Center
RECRUITING
Jacksonville
Tampa General Hospital (Cancer Institute)
WITHDRAWN
Tampa
Georgia
Winship Cancer Institute, Emory University
RECRUITING
Atlanta
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System
RECRUITING
Savannah
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
Indiana
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
RECRUITING
Indianapolis
Kentucky
Baptist Health Lexington
RECRUITING
Lexington
Norton Cancer Institute
RECRUITING
Louisville
Louisiana
Women's Cancer Care
WITHDRAWN
Covington
Ochsner Clinic Foundation
RECRUITING
New Orleans
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Baystate Medical Center
RECRUITING
Springfield
Maryland
Greater Baltimore Medical Center
RECRUITING
Baltimore
Michigan
West Michigan Cancer Center
RECRUITING
Kalamazoo
Minnesota
M Health Fairview University of Minnesota Medical Center - East Bank Hospital
RECRUITING
Minneapolis
Metro Minnesota Community Oncology Research Consortium (MMCORC)
RECRUITING
Saint Louis Park
Missouri
MidAmerica Division, Inc. c/o Research Medical Center
RECRUITING
Kansas City
Mississippi
University of Mississippi Medical Center
NOT_YET_RECRUITING
Jackson
North Carolina
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Rutgers Cancer Institute
RECRUITING
New Brunswick
New Mexico
University of New Mexico Comprehensive Cancer Center
RECRUITING
Albuquerque
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Northwell Health Cancer Institute
RECRUITING
Lake Success
Columbia University Medical Center, Herbert Irving Pavilion
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
SUNY Upstate Medical University
RECRUITING
Syracuse
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Ohio Health Research Institute
RECRUITING
Columbus
Oklahoma
Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
RECRUITING
Tulsa
Oregon
Providence Cancer Institute Franz Clinic
RECRUITING
Portland
Pennsylvania
Alliance Cancer Specialists, PC
RECRUITING
Horsham
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
RECRUITING
Philadelphia
South Carolina
MUSC Hollings Cancer Center
RECRUITING
Charleston
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Texas Oncology
RECRUITING
Fort Worth
Baylor College of Medicine Medical Center
RECRUITING
Houston
The University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Virginia
University of Virginia Comprehensive Cancer Center
RECRUITING
Charlottesville
Virginia Oncology Associates
RECRUITING
Norfolk
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Wisconsin
University of Wisconsin Carbone Cancer Center
RECRUITING
Madison
Froedtert and the Medical College of Wisconsin (MCW)
RECRUITING
Milwaukee
Other Locations
Australia
Chris O'Brien Lifehouse
RECRUITING
Camperdown
Canberra Hospital
RECRUITING
Canberra
Monash Health
RECRUITING
Clayton
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Sir Charles Gairdner Hospital
RECRUITING
Murdoch
Mater Cancer Care Centre
RECRUITING
South Brisbane
Brazil
Clínica de Neoplasias Litoral
RECRUITING
Itajaí
Centro de Pesquisa Clínica do Hospital Moinhos de Vento
RECRUITING
Porto Alegre
Hospital Santa Joana Recife
NOT_YET_RECRUITING
Recife
Instituto D'Or Pesquisa e Ensino
RECRUITING
Rio De Janeiro
Ensino e Terapia de Inovação Clínica AMO - ETICA
RECRUITING
Salvador
AC Camargo Cancer Center (Fundação Antonio Prudente)
RECRUITING
São Paulo
BP - A Beneficência Portuguesa da São Paulo / Hospital BP Mirante
RECRUITING
São Paulo
DASA - Hospital 9 de Julho
RECRUITING
São Paulo
Instituto do Câncer do Estado de São Paulo
RECRUITING
São Paulo
Canada
Arthur J. E. Child Comprehensive Cancer Centre
RECRUITING
Calgary
London Health Sciences Centre
RECRUITING
London
McGill University Health Centre - Glen Site
RECRUITING
Montreal
CIC-CHU de Québec-Université Laval- Hôpital de l'Enfant-Jésus
RECRUITING
Québec
Princess Margaret Cancer Centre
RECRUITING
Toronto
Sunnybrook Research Institute
RECRUITING
Toronto
China
Beijing Cancer Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
West China Second Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Guangxi Medical University Affiliated Tumor Hospital
RECRUITING
Guangxi Zhuang Autonomous Region
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Women's Hospital School Of Medicine Zhejiang University
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Jiangxi Maternal and Child Health Hospital
RECRUITING
Nanchang
Fudan University Shanghai Cancer Center
ACTIVE_NOT_RECRUITING
Shanghai
Shanghai Tenth People's Hospital
RECRUITING
Shanghai
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Tongji Hospital, Tongji Medical College of HUST
RECRUITING
Wuhan
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
Henan Cancer Hospital
RECRUITING
Zhengzhou
France
Centre Francois Baclesse
RECRUITING
Caen
Institut Paoli Calmettes
RECRUITING
Marseille
Centre Antoine Lacassagne
RECRUITING
Nice
Hôpital Cochin
RECRUITING
Paris
HCL - Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
ICO - Centre René Gauducheau
RECRUITING
Saint-herblain
Institut de Cancerologie de Lorraine
RECRUITING
Vandœuvre-lès-nancy
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
Hochtaunus Kliniken Bad Homburg
RECRUITING
Bad Homburg
Universitatsklinikum Dusseldorf
RECRUITING
Düsseldorf
University Hospital Essen
RECRUITING
Essen
Universitätsklinikum Hamburg
RECRUITING
Hamburg
Medical School Hannover
RECRUITING
Hanover
University Hospital Leipzig
RECRUITING
Leipzig
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde
RECRUITING
München
Universitätsklinikum Ulm
RECRUITING
Ulm
Greece
Aretaeion Hospital
RECRUITING
Athens
MITERA hospital
RECRUITING
Athens
Kalamata Hospital
RECRUITING
Kalamata
General Hospital of Patras Agios Andreas
RECRUITING
Pátrai
St. Luke's Hospital
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Hong Kong Sanatorium & Hospital
RECRUITING
Happy Valley
Queen Mary Hospital
RECRUITING
Hong Kong
Prince of Wales Hospital
RECRUITING
New Territories
Israel
Hillel Yaffe Medical Center
RECRUITING
Hadera
Rambam Health Care Campus
RECRUITING
Haifa
Wolfson Medical Center
RECRUITING
Holon
Hadassah Medical Center
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Ramat Gan
Sourasky T.A.M.C.
RECRUITING
Tel Aviv
Italy
SOC di Oncologia Medica e Prevenzione Oncologica Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
RECRUITING
Aviano
Azienda Ospedaliera Universitaria Careggi - Unita di Oncologia Ginecologica
RECRUITING
Florence
ASST Lecco - Ospedale Alessandro Manzoni
RECRUITING
Lecco
Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
RECRUITING
Meldola
Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
RECRUITING
Milan
Irccs Ospedale San Raffaele-UO Ginecologia
RECRUITING
Milan
Istituto Europeo di Oncologia
RECRUITING
Milan
Istituto Oncologico Veneto IRCCS
RECRUITING
Padua
Azienda Ospedaliero Universitaria Pisana, Ospedale Santa Chiara
RECRUITING
Pisa
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING
Roma
Istituto Nazionale Tumori Regina Elena IRCCS
RECRUITING
Rome
A.O. Ordine Mauriziano di Torino
RECRUITING
Torino
AOU Città della Salute e della Scienza di Torino - Presidio Sant'Anna
RECRUITING
Torino
Japan
Chiba Cancer Center
RECRUITING
Chiba
The Jikei University Kashiwa Hospital
RECRUITING
Chiba
Hyogo Cancer Center
RECRUITING
Hyōgo
St. Marianna University Hospital
RECRUITING
Kanagawa
Mie University Hospital
RECRUITING
Mie
Okayama University Hospital
RECRUITING
Okayama
Saitama Medical University International Medical Center
RECRUITING
Saitama
Shizuoka Cancer Center
RECRUITING
Shizuoka
National Cancer Center Hospital
RECRUITING
Tokyo
The Cancer Institute Hospital Of JFCR
RECRUITING
Tokyo
Poland
Szpitale Pomorskie Sp. z o.o.
RECRUITING
Gdynia
Uniwersyteckie Centrum Kliniczne SUM
RECRUITING
Katowice
Oddział Ginekologii Onkologicznej Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
RECRUITING
Siedlce
Dolnoslaskie Centrum Onkologii
RECRUITING
Wroclaw
Republic of Korea
Keimyung University Dongsan Medical Center
RECRUITING
Dalseo-gu
National Cancer Center - Korea
RECRUITING
Goyang-si
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Spain
Complexo Hospitalario Universitario A Coruna
RECRUITING
A Coruña
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitario Ciudad de Jaen
RECRUITING
Jaén
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitari Son Espases
RECRUITING
Palma
Hospital Parc Taulí
RECRUITING
Sabadell
Hospital Universitario Donostia
RECRUITING
San Sebastián
Hospital Universitario La Fe - Valencia
RECRUITING
Valencia
Taiwan
Kaohsiung Veterans General Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
Mackay Memorial Hospital
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital, Linkou
RECRUITING
Taoyuan
United Kingdom
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary
RECRUITING
Leicester
University College London Hospitals
RECRUITING
London
East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre
RECRUITING
Northwood
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2024-08-28
Estimated Completion Date: 2029-06
Participants
Target number of participants: 640
Treatments
Experimental: Sacituzumab Govitecan (SG)
Participants will receive SG at a dose of 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Active_comparator: Treatment of Physician's Choice (TPC)
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
Related Therapeutic Areas
Sponsors
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group (APGOT), GOG Foundation
Leads: Gilead Sciences