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 (104)

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

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States, 80045

Yale University School of Medicine

New Haven, Connecticut, United States, 06520

Florida Cancer Specialists

Fort Myers, Florida, United States, 33901

Tampa General Hospital (Cancer Institute)

Tampa, Florida, United States, 33606

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

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

Women's Cancer Care

Covington, Louisiana, United States, 70433

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

Rutgers Cancer Institute

New Brunswick, New Jersey, United States, 08901

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States, 87131

Northwell Health Cancer Institute

Lake Success, New York, United States, 11042

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

Alliance Cancer Specialists, PC

Horsham, Pennsylvania, United States, 19044

University of Pennsylvania Health System, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Texas Oncology

Fort Worth, Texas, United States, 76104

Baylor College of Medicine Medical 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

Monash Health

Clayton, Victoria, Australia, 3168

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Beijing Cancer Hospital

Beijing, China, 100142

The First Hospital of Jilin University

Changchun, China, 130021

Chongqing University Cancer Hospital

Chongqing, China, 400030

Guangxi Medical University Affiliated Tumor Hospital

Guangxi Zhuang Autonomous Region, China, 530021

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 City, China, 430022

Tongji Hospital, Tongji Medical College of HUST

Wuhan, China, 430030

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China, 710061

University Hospital Bulovka

Prague, Czechia, 180 81

Centre Antoine Lacassagne

Nice, France, 06189

Hôpital Cochin

Paris, France, 75014

HCL - Centre Hospitalier Lyon Sud

Pierre Benite, France, 69130

Institut de Cancerologie de Lorraine

Vandoeuvre Les Nancy, France, 54519

University Hospital Essen

Essen, Germany, 45147

Universitätsklinikum Hamburg

Hamburg, Germany, 20246

St. Luke's Hospital

Thessaloniki, Greece, 55236

Queen Mary Hospital

Hong Kong, Hong Kong, 999077

Prince of Wales Hospital

New Territories, Hong Kong, 999077

Rambam Health Care Campus

Haifa, Israel, 3501602

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

Firenze, 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

Istituto Europeo di Oncologia

Milan, Italy, 20141

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

A.O. Ordine Mauriziano di Torino

Torino, Italy, 10128

Chiba Cancer Center

Chiba, Japan, 260-8717

Chiba Cancer Center

Chiba, Japan, 277-8567

Hyogo Cancer Center

Hyogo, Japan, 673-8558

Mie University Hospital

Mie, Japan, 514-8507

Okayama University Hospital

Okayama, Japan, 700-8558

National Cancer Center Hospital

Tokyo, Japan, 104-0045

The Cancer Institute Hospital Of JFCR

Tokyo, Japan, 135-8550

Keimyung University Dongsan Medical Center

Dalseo-gu, Korea, Republic of, 41931

National Cancer Center - Korea

Goyang-si, Korea, Republic of, 10408

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Asan Medical Center

Seoul, Korea, Republic of, 05505

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Severance Hospital

Seoul, Korea, Republic of, 0

Szpitale Pomorskie Sp. z o.o.

Gdynia, Poland, 81-519

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

Siedlce, Poland, 08-110

National University Hospital

Singapore, Singapore, 119074

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 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 Universitario La Fe - Valencia

Valencia, Spain, 46026

Kaohsiung Veterans General Hospital

Kaohsiung, 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 City, Taiwan

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom, LS9 7TF

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)