Study Details

OVERVIEW

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 (ASCENT-GYN-01)

PROTOCOL 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).

Participation Requirements

Age

18 Years +

Sex

FEMALE

Healthy Volunteers

Medical Condition

Endometrial Cancer

Gender

N/A

Date

August 2024 - June 2029

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Sacituzumab govitecan-hziy, Doxorubicin, Paclitaxel

Eligibility Information

Inclusion Criteria

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

Exclusion Criteria

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.

Locations

Locations (189)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

City of Hope

Duarte, California, United States, 91010

UC San Diego Medical Center

La Jolla, California, United States, 92093

Cedars-Sinai Cancer at Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Stanford Women's Cancer Center

Palo Alto, California, United States, 94304

Kaiser Permanente Medical Center

Vallejo, California, United States, 94589

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States, 80045

Hartford HealthCare Cancer Institute at Hartford Hospital

Hartford, Connecticut, United States, 06102

Yale University School of Medicine

New Haven, Connecticut, United States, 06520

Florida Cancer Specialists

Fort Myers, Florida, United States, 33901

University of Florida

Gainesville, Florida, United States, 32610

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States, 32207

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System

Savannah, Georgia, United States, 31405

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States, 46202

Baptist Health Lexington

Lexington, Kentucky, United States, 40503

Norton Cancer Institute

Louisville, Kentucky, United States, 40207

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

Greater Baltimore Medical Center

Baltimore, Maryland, United States, 21204

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

West Michigan Cancer Center

Kalamazoo, Michigan, United States, 49007

M Health Fairview University of Minnesota Medical Center - East Bank Hospital

Minneapolis, Minnesota, United States, 55455

Metro Minnesota Community Oncology Research Consortium (MMCORC)

Saint Louis Park, Minnesota, United States, 55426

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

MidAmerica Division, Inc. c/o Research Medical Center

Kansas City, Missouri, United States, 64132

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68105

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Rutgers Cancer Institute

New Brunswick, New Jersey, United States, 08901

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States, 87131

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Northwell Health Cancer Institute

Lake Success, New York, United States, 11042

Columbia University Medical Center, Herbert Irving Pavilion

New York, New York, United States, 10032

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

University of Rochester Medical Center

Rochester, New York, United States, 14642

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27103

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Ohio Health Research Institute

Columbus, Ohio, United States, 43214

Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa

Tulsa, Oklahoma, United States, 74146

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States, 97213

Alliance Cancer Specialists, PC

Horsham, Pennsylvania, United States, 19044

University of Pennsylvania Health System, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

MUSC Hollings Cancer Center

Charleston, South Carolina, United States, 29485

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Texas Oncology

Fort Worth, Texas, United States, 76104

Baylor College of Medicine Medical Center

Houston, Texas, United States, 77030

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States, 22908

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States, 53792

Froedtert and the Medical College of Wisconsin (MCW)

Milwaukee, Wisconsin, United States, 53226

Canberra Hospital

Canberra, Australian Capital Territory, Australia, 2605

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia, 2050

Mater Cancer Care Centre

South Brisbane, Queensland, Australia, 4101

Monash Health

Clayton, Victoria, Australia, 3168

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Sir Charles Gairdner Hospital

Murdoch, Western Australia, Australia, 6150

Clínica de Neoplasias Litoral

Itajaí, Brazil, 88301-220

Centro de Pesquisa Clínica do Hospital Moinhos de Vento

Porto Alegre, Brazil, 90035001

Hospital Santa Joana Recife

Recife, Brazil, 52011906

Instituto D'Or Pesquisa e Ensino

Rio de Janeiro, Brazil, 22281-100

Ensino e Terapia de Inovação Clínica AMO - ETICA

Salvador, Brazil, 41950640

Instituto do Câncer do Estado de São Paulo

São Paulo, Brazil, 01246-000

BP - A Beneficência Portuguesa da São Paulo / Hospital BP Mirante

São Paulo, Brazil, 01321-001

DASA - Hospital 9 de Julho

São Paulo, Brazil, 01409-002

AC Camargo Cancer Center (Fundação Antonio Prudente)

São Paulo, Brazil, 01509-900

Arthur J. E. Child Comprehensive Cancer Centre

Calgary, Canada, T2N 5G2

London Health Sciences Centre

London, Canada, N6A 5W9

McGill University Health Centre - Glen Site

Montreal, Canada, H4A 3J1

CIC-CHU de Québec-Université Laval- Hôpital de l'Enfant-Jésus

Québec, Canada, G1G 5X1

Sunnybrook Research Institute

Toronto, Canada, M4N 3M5

Princess Margaret Cancer Centre

Toronto, Canada, M5G 2M9

Beijing Cancer Hospital

Beijing, China, 100142

The First Hospital of Jilin University

Changchun, China, 130021

Hunan Cancer Hospital

Changsha, China, 410013

West China Second Hospital of Sichuan University

Chengdu, China, 610041

Chongqing University Cancer Hospital

Chongqing, China, 400030

Guangxi Medical University Affiliated Tumor Hospital

Guangxi Zhuang Autonomous Region, China, 530021

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, China, 61020

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, China, 310006

Zhejiang Cancer Hospital

Hangzhou, China, 310022

Harbin Medical University Cancer Hospital

Harbin, China, 150081

Jiangxi Maternal and Child Health Hospital

Nanchang, China, 330006

Fudan University Shanghai Cancer Center

Shanghai, China, 200032

Shanghai Tenth People's Hospital

Shanghai, China, 200072

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China, 300060

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China, 430022

Tongji Hospital, Tongji Medical College of HUST

Wuhan, China, 430030

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China, 710061

Henan Cancer Hospital

Zhengzhou, China, 450003

Nemocnice AGEL, Nový Jičín a.s.

Nový Jičín, Czechia, 74101

University Hospital Ostrava

Ostrava-Poruba, Czechia, 708 52

General University Hospital in Prague

Prague, Czechia, 128 08

University Hospital Bulovka

Prague, Czechia, 180 81

Centre Francois Baclesse

Caen, France, 14076

Institut Paoli Calmettes

Marseille, France, 13009

Centre Antoine Lacassagne

Nice, France, 06189

Hôpital Cochin

Paris, France, 75014

HCL - Centre Hospitalier Lyon Sud

Pierre-Bénite, France, 69130

ICO - Centre René Gauducheau

Saint-Herblain, France, 44805

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France, 54519

Institut Gustave Roussy

Villejuif, France, 94805

Hochtaunus Kliniken Bad Homburg

Bad Homburg, Germany, 61352

Universitatsklinikum Dusseldorf

Düsseldorf, Germany, 40225

University Hospital Essen

Essen, Germany, 45147

Universitätsklinikum Hamburg

Hamburg, Germany, 20246

Medical School Hannover

Hanover, Germany, 30625

University Hospital Leipzig

Leipzig, Germany, 04103

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

München, Germany, 81675

Universitätsklinikum Ulm

Ulm, Germany, 89075

Aretaeion Hospital

Athens, Greece, 11528

MITERA hospital

Athens, Greece, 15123

Kalamata Hospital

Kalamata, Greece, 241 00

General Hospital of Patras Agios Andreas

Pátrai, Greece, 26335

St. Luke's Hospital

Thessaloniki, Greece, 55236

Hong Kong Sanatorium & Hospital

Happy Valley, Hong Kong, 999077

Queen Mary Hospital

Hong Kong, Hong Kong, 999077

Prince of Wales Hospital

New Territories, Hong Kong, 999077

Hillel Yaffe Medical Center

Hadera, Israel, 3810101

Rambam Health Care Campus

Haifa, Israel, 3501602

Wolfson Medical Center

Holon, Israel, 58100

Hadassah Medical Center

Jerusalem, Israel, 91120

Sheba Medical Center

Ramat Gan, Israel, 52621

Sourasky T.A.M.C.

Tel Aviv, Israel, 6423906

SOC di Oncologia Medica e Prevenzione Oncologica Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

Aviano, Italy, 33081

Azienda Ospedaliera Universitaria Careggi - Unita di Oncologia Ginecologica

Florence, Italy, 50134

ASST Lecco - Ospedale Alessandro Manzoni

Lecco, Italy, 23900

Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST

Meldola, Italy, 47014

Irccs Ospedale San Raffaele-UO Ginecologia

Milan, Italy, 20132

Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano

Milan, Italy, 20133

Istituto Europeo di Oncologia

Milan, Italy, 20141

Istituto Oncologico Veneto IRCCS

Padua, Italy, 35128

Azienda Ospedaliero Universitaria Pisana, Ospedale Santa Chiara

Pisa, Italy, 56126

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy, 168

Istituto Nazionale Tumori Regina Elena IRCCS

Rome, Italy, 00 144

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

Torino, Italy, 10126

A.O. Ordine Mauriziano di Torino

Torino, Italy, 10128

Chiba Cancer Center

Chiba, Japan, 260-8717

The Jikei University Kashiwa Hospital

Chiba, Japan, 277-8567

Hyogo Cancer Center

Hyōgo, Japan, 673-8558

St. Marianna University Hospital

Kanagawa, Japan, 216-8511

Mie University Hospital

Mie, Japan, 514-8507

Okayama University Hospital

Okayama, Japan, 700-8558

Saitama Medical University International Medical Center

Saitama, Japan, 350-1241

Shizuoka Cancer Center

Shizuoka, Japan, 411-8777

National Cancer Center Hospital

Tokyo, Japan, 104-0045

The Cancer Institute Hospital Of JFCR

Tokyo, Japan, 135-8550

Szpitale Pomorskie Sp. z o.o.

Gdynia, Poland, 81-519

Uniwersyteckie Centrum Kliniczne SUM

Katowice, Poland, 50-752

Oddział Ginekologii Onkologicznej Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland, 60-569

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

Siedlce, Poland, 08-110

Dolnoslaskie Centrum Onkologii

Wroclaw, Poland, 53-413

National University Hospital

Singapore, Singapore, 119074

National Cancer Centre Singapore

Singapore, Singapore, 168583

Keimyung University Dongsan Medical Center

Dalseo-gu, South Korea, 41931

National Cancer Center - Korea

Goyang-si, South Korea, 10408

Seoul National University Hospital

Seoul, South Korea, 03080

Asan Medical Center

Seoul, South Korea, 05505

Samsung Medical Center

Seoul, South Korea, 06351

Severance Hospital

Seoul, South Korea, 0

Complexo Hospitalario Universitario A Coruna

A Coruña, Spain, 15007

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital Universitario Ciudad de Jaen

Jaén, Spain, 23007

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28009

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Hospital Universitario Clinico San Carlos

Madrid, Spain, 28040

Hospital Universitario Virgen de la Victoria

Málaga, Spain, 2910

Hospital Universitari Son Espases

Palma, Spain, 07120

Hospital Parc Taulí

Sabadell, Spain, 08208

Hospital Universitario Donostia

San Sebastián, Spain, 20014

Hospital Universitario La Fe - Valencia

Valencia, Spain, 46026

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan, 813

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

National Cheng Kung University Hospital

Tainan, Taiwan, 704

National Taiwan University Hospital

Taipei, Taiwan, 10002

Mackay Memorial Hospital

Taipei, Taiwan, 104

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan

Birmingham Heartlands Hospital

Birmingham, United Kingdom, B75 7RR

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom, CB2 0QQ

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom, LS9 7TF

University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

University College London Hospitals

London, United Kingdom, NW1 2PG

East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre

Northwood, United Kingdom, HA6 2RN

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) (ASCENT-GYN-01)