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)

Last updated: June 23, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

3

Condition

Endometriosis

Vaginal Cancer

Pelvic Cancer

Treatment

Doxorubicin

Sacituzumab govitecan-hziy

Paclitaxel

Clinical Study ID

NCT06486441
GS-US-682-6769
ENGOT-en26
2024-511957-23
GOG-3104
APGOT-EN2
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Key Inclusion Criteria:

  • Documented evidence of recurrent/persistent endometrial cancer (endometrialcarcinoma or carcinosarcoma).

  • Up to 3 prior lines of systemic therapy for endometrial cancer, including systemicplatinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination orseparately.

  • Eligible for treatment with either doxorubicin or paclitaxel as determined by theinvestigator.

  • Radiologically evaluable disease (either measurable or nonmeasurable) by computedtomography (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

Key Exclusion Criteria:

  • Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded.

  • Participants who are candidates for curative-intent therapy at the time of studyenrollment.

  • Participants eligible for rechallenge with platinum-based chemotherapy as determinedby 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 areassigned female at birth.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 520
Treatment Group(s): 3
Primary Treatment: Doxorubicin
Phase: 3
Study Start date:
August 28, 2024
Estimated Completion Date:
June 30, 2029

Connect with a study center

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Mater Cancer Care Centre

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Clínica de Neoplasias Litoral

    Itajai, 88301-220
    Brazil

    Active - Recruiting

  • Ensino e Terapia de Inovação Clínica AMO - ETICA

    Salvador, 41950640
    Brazil

    Active - Recruiting

  • London Health Sciences Centre

    London, N6A 5W9
    Canada

    Active - Recruiting

  • McGill University Health Centre - Glen Site

    Montreal, H4A 3J1
    Canada

    Active - Recruiting

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

    Quebec, G1G 5X1
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, M5G 2M9
    Canada

    Active - Recruiting

  • Sunnybrook Research Institute

    Toronto, M4N 3M5
    Canada

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, 130021
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, 410013
    China

    Active - Recruiting

  • West China Second Hospital of Sichuan University

    Chengdu, 610041
    China

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400030
    China

    Active - Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Guangxi Zhuang Autonomous Region, 530021
    China

    Active - Recruiting

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

    Guangzhou, 61020
    China

    Active - Recruiting

  • Women's Hospital School Of Medicine Zhejiang University

    Hangzhou, 310006
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081
    China

    Active - Recruiting

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, 330006
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Site Not Available

  • Shanghai Tenth People's Hospital

    Shanghai, 200072
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060
    China

    Active - Recruiting

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, 430030
    China

    Active - Recruiting

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

    Wuhan City, 430022
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, 450003
    China

    Active - Recruiting

  • Nemocnice AGEL, Nový Jičín a.s.

    Nový Jičín, 74101
    Czechia

    Active - Recruiting

  • General University Hospital in Prague

    Prague, 128 08
    Czechia

    Active - Recruiting

  • University Hospital Bulovka

    Prague, 180 81
    Czechia

    Active - Recruiting

  • Centre Francois Baclesse

    Caen Cedex 5, 14076
    France

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille, 13009
    France

    Active - Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Active - Recruiting

  • Hôpital Cochin

    Paris, 75014
    France

    Active - Recruiting

  • HCL - Centre Hospitalier Lyon Sud

    Pierre Benite, 69130
    France

    Active - Recruiting

  • ICO - Centre René Gauducheau

    Saint-Herblain, 44805
    France

    Active - Recruiting

  • Institut de Cancerologie de Lorraine

    Vandoeuvre Les Nancy, 54519
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Hochtaunus Kliniken Bad Homburg

    Bad Homburg, 61352
    Germany

    Active - Recruiting

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • University Hospital Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitätsklinikum Hamburg

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Medical School Hannover

    Hannover, 30625
    Germany

    Active - Recruiting

  • University Hospital Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

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

    München, 81675
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89075
    Germany

    Active - Recruiting

  • Aretaeion Hospital

    Athens, 11528
    Greece

    Active - Recruiting

  • Kalamata Hospital

    Kalamata, 241 00
    Greece

    Active - Recruiting

  • General Hospital of Patras Agios Andreas

    Patras, 26335
    Greece

    Active - Recruiting

  • St. Luke's Hospital

    Thessaloniki, 55236
    Greece

    Active - Recruiting

  • Hong Kong Sanatorium & Hospital

    Happy Valley, 999077
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong, 999077
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital

    New Territories, 999077
    Hong Kong

    Active - Recruiting

  • Hillel Yaffe Medical Center

    Hadera, 3810101
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, 3501602
    Israel

    Active - Recruiting

  • Wolfson Medical Center

    Holon, 58100
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Sourasky T.A.M.C.

    Tel Aviv-Yaffo, 6423906
    Israel

    Active - Recruiting

  • Sheba Medical Center

    ramat GAn, 52621
    Israel

    Active - Recruiting

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

    Aviano, 33081
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi - Unita di Oncologia Ginecologica

    Firenze, 50134
    Italy

    Active - Recruiting

  • ASST Lecco - Ospedale Alessandro Manzoni

    Lecco, 23900
    Italy

    Active - Recruiting

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

    Meldola, 47014
    Italy

    Active - Recruiting

  • Irccs Ospedale San Raffaele-UO Ginecologia

    Milan, 20132
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141
    Italy

    Active - Recruiting

  • Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano

    Milano, 20133
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana, Ospedale Santa Chiara

    Pisa, 56126
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 168
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Regina Elena IRCCS

    Rome, 00 144
    Italy

    Active - Recruiting

  • A.O. Ordine Mauriziano di Torino

    Torino, 10128
    Italy

    Active - Recruiting

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

    Torino, 10126
    Italy

    Active - Recruiting

  • Chiba Cancer Center

    Chiba, 260-8717
    Japan

    Active - Recruiting

  • The Jikei University Kashiwa Hospital

    Chiba, 277-8567
    Japan

    Active - Recruiting

  • Hyogo Cancer Center

    Hyogo, 673-8558
    Japan

    Active - Recruiting

  • St. Marianna University Hospital

    Kanagawa, 216-8511
    Japan

    Active - Recruiting

  • Mie University Hospital

    Mie, 514-8507
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Saitama Medical University International Medical Center

    Saitama, 350-1241
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Shizuoka, 411-8777
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital Of JFCR

    Tokyo, 135-8550
    Japan

    Active - Recruiting

  • Keimyung University Dongsan Medical Center

    Dalseo-gu, 41931
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center - Korea

    Goyang-si, 10408
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 0
    Korea, Republic of

    Active - Recruiting

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, 81-519
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne SUM

    Katowice, 50-752
    Poland

    Active - Recruiting

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

    Siedlce, 08-110
    Poland

    Active - Recruiting

  • National Cancer Centre Singapore

    Singapore, 168583
    Singapore

    Active - Recruiting

  • National University Hospital

    Singapore, 119074
    Singapore

    Active - Recruiting

  • Complexo Hospitalario Universitario A Coruna

    A Coruña, 15007
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitario Ciudad de Jaen

    Jaén, 23007
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009
    Spain

    Active - Recruiting

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 2910
    Spain

    Active - Recruiting

  • Hospital Universitari Son Espases

    Palma, 07120
    Spain

    Active - Recruiting

  • Hospital Parc Taulí

    Sabadell, 08208
    Spain

    Active - Recruiting

  • Hospital Universitario Donostia

    San Sebastián, 20014
    Spain

    Active - Recruiting

  • Hospital Universitario La Fe - Valencia

    Valencia, 46026
    Spain

    Active - Recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 813
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital

    Taipei, 104
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City,
    Taiwan

    Active - Recruiting

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF
    United Kingdom

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  • University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary

    Leicester, LE1 5WW
    United Kingdom

    Active - Recruiting

  • University College London Hospitals

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre

    Northwood, HA6 2RN
    United Kingdom

    Active - Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope

    Irvine, California 92618
    United States

    Site Not Available

  • UC San Diego Medical Center

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Stanford Women's Cancer Center

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Kaiser Permanente Medical Center

    Vallejo, California 94589
    United States

    Active - Recruiting

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Hartford HealthCare Cancer Institute at Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Active - Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Fort Myers, Florida 33901
    United States

    Active - Recruiting

  • Florida Cancer Specialists MAIN

    Fort Myers, Florida 33901
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Tampa General Hospital (Cancer Institute)

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

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

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Women's Cancer Care

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Greater Baltimore Medical Center

    Baltimore, Maryland 21204
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Active - Recruiting

  • West Michigan Cancer Center

    Kalamazoo, Michigan 49007
    United States

    Active - Recruiting

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

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • MMCORC

    Saint Louis Park, Minnesota 55426
    United States

    Active - Recruiting

  • Metro Minnesota Community Oncology Research Consortium (MMCORC)

    Saint Louis Park, Minnesota 55426
    United States

    Active - Recruiting

  • MidAmerica Division, Inc. c/o Research Medical Center

    Kansas City, Missouri 64132
    United States

    Active - Recruiting

  • Rutgers Cancer Institute

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Northwell Health Cancer Institute

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Columbia University Medical Center, Herbert Irving Pavilion

    New York, New York 10032
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Ohio Health Research Institute

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa

    Tulsa, Oklahoma 74146
    United States

    Active - Recruiting

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Alliance Cancer Specialists, PC

    Horsham, Pennsylvania 19044
    United States

    Active - Recruiting

  • University of Pennsylvania Health System, Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • MUSC Hollings Cancer Center

    Charleston, South Carolina 29485
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Texas Oncology

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Baylor College of Medicine Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • Froedtert and the Medical College of Wisconsin (MCW)

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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