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
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
5 other identifiers
interventional
640
19 countries
189
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2024
Longer than P75 for phase_3
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedStudy Start
First participant enrolled
August 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
January 15, 2026
January 1, 2026
4.8 years
June 27, 2024
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR)
PFS, defined as the time from the date of randomization until the date of objective progressive disease (PD), as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever comes first.
Up to approximately 27 months
Overall Survival (OS)
Overall survival (OS) is defined as time from the date of randomization until death due to any cause.
Up to approximately 47 months
Secondary Outcomes (9)
Objective Response Rate (ORR) as Assessed by BICR
Up to approximately 47 months
Change from Baseline in the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 16
Baseline, Week 16
PFS as Assessed by Investigator
Up to approximately 27 months
ORR as Assessed by Investigator
Up to approximately 47 months
Duration of Response (DOR) as Assessed by BICR and Investigator
Up to approximately 47 months
- +4 more secondary outcomes
Study Arms (2)
Sacituzumab Govitecan (SG)
EXPERIMENTALParticipants will receive SG at a dose of 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Treatment of Physician's Choice (TPC)
ACTIVE COMPARATORParticipants 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
Interventions
Administered intravenously
Administered intravenously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- GOG Foundationcollaborator
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
- Asia-Pacific Gynecologic Oncology Trials Group (APGOT)collaborator
Study Sites (189)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
City of Hope
Duarte, California, 91010, United States
UC San Diego Medical Center
La Jolla, California, 92093, United States
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford Women's Cancer Center
Palo Alto, California, 94304, United States
Kaiser Permanente Medical Center
Vallejo, California, 94589, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045, United States
Hartford HealthCare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
University of Florida
Gainesville, Florida, 32610, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System
Savannah, Georgia, 31405, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
M Health Fairview University of Minnesota Medical Center - East Bank Hospital
Minneapolis, Minnesota, 55455, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, 55426, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
MidAmerica Division, Inc. c/o Research Medical Center
Kansas City, Missouri, 64132, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Northwell Health Cancer Institute
Lake Success, New York, 11042, United States
Columbia University Medical Center, Herbert Irving Pavilion
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
Tulsa, Oklahoma, 74146, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044, United States
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, 29485, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Oncology
Fort Worth, Texas, 76104, United States
Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22908, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Froedtert and the Medical College of Wisconsin (MCW)
Milwaukee, Wisconsin, 53226, United States
Canberra Hospital
Canberra, Australian Capital Territory, 2605, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Mater Cancer Care Centre
South Brisbane, Queensland, 4101, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Sir Charles Gairdner Hospital
Murdoch, Western Australia, 6150, Australia
Clínica de Neoplasias Litoral
Itajaí, 88301-220, Brazil
Centro de Pesquisa Clínica do Hospital Moinhos de Vento
Porto Alegre, 90035001, Brazil
Hospital Santa Joana Recife
Recife, 52011906, Brazil
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro, 22281-100, Brazil
Ensino e Terapia de Inovação Clínica AMO - ETICA
Salvador, 41950640, Brazil
Instituto do Câncer do Estado de São Paulo
São Paulo, 01246-000, Brazil
BP - A Beneficência Portuguesa da São Paulo / Hospital BP Mirante
São Paulo, 01321-001, Brazil
DASA - Hospital 9 de Julho
São Paulo, 01409-002, Brazil
AC Camargo Cancer Center (Fundação Antonio Prudente)
São Paulo, 01509-900, Brazil
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, T2N 5G2, Canada
London Health Sciences Centre
London, N6A 5W9, Canada
McGill University Health Centre - Glen Site
Montreal, H4A 3J1, Canada
CIC-CHU de Québec-Université Laval- Hôpital de l'Enfant-Jésus
Québec, G1G 5X1, Canada
Sunnybrook Research Institute
Toronto, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, M5G 2M9, Canada
Beijing Cancer Hospital
Beijing, 100142, China
The First Hospital of Jilin University
Changchun, 130021, China
Hunan Cancer Hospital
Changsha, 410013, China
West China Second Hospital of Sichuan University
Chengdu, 610041, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Guangxi Medical University Affiliated Tumor Hospital
Guangxi Zhuang Autonomous Region, 530021, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, 61020, China
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, 310006, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Jiangxi Maternal and Child Health Hospital
Nanchang, 330006, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Shanghai Tenth People's Hospital
Shanghai, 200072, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, 430030, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
Henan Cancer Hospital
Zhengzhou, 450003, China
Nemocnice AGEL, Nový Jičín a.s.
Nový Jičín, 74101, Czechia
University Hospital Ostrava
Ostrava-Poruba, 708 52, Czechia
General University Hospital in Prague
Prague, 128 08, Czechia
University Hospital Bulovka
Prague, 180 81, Czechia
Centre Francois Baclesse
Caen, 14076, France
Institut Paoli Calmettes
Marseille, 13009, France
Centre Antoine Lacassagne
Nice, 06189, France
Hôpital Cochin
Paris, 75014, France
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69130, France
ICO - Centre René Gauducheau
Saint-Herblain, 44805, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Institut Gustave Roussy
Villejuif, 94805, France
Hochtaunus Kliniken Bad Homburg
Bad Homburg, 61352, Germany
Universitatsklinikum Dusseldorf
Düsseldorf, 40225, Germany
University Hospital Essen
Essen, 45147, Germany
Universitätsklinikum Hamburg
Hamburg, 20246, Germany
Medical School Hannover
Hanover, 30625, Germany
University Hospital Leipzig
Leipzig, 04103, Germany
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde
München, 81675, Germany
Universitätsklinikum Ulm
Ulm, 89075, Germany
Aretaeion Hospital
Athens, 11528, Greece
MITERA hospital
Athens, 15123, Greece
Kalamata Hospital
Kalamata, 241 00, Greece
General Hospital of Patras Agios Andreas
Pátrai, 26335, Greece
St. Luke's Hospital
Thessaloniki, 55236, Greece
Hong Kong Sanatorium & Hospital
Happy Valley, 999077, Hong Kong
Queen Mary Hospital
Hong Kong, 999077, Hong Kong
Prince of Wales Hospital
New Territories, 999077, Hong Kong
Hillel Yaffe Medical Center
Hadera, 3810101, Israel
Rambam Health Care Campus
Haifa, 3501602, Israel
Wolfson Medical Center
Holon, 58100, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Sourasky T.A.M.C.
Tel Aviv, 6423906, Israel
SOC di Oncologia Medica e Prevenzione Oncologica Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
Aviano, 33081, Italy
Azienda Ospedaliera Universitaria Careggi - Unita di Oncologia Ginecologica
Florence, 50134, Italy
ASST Lecco - Ospedale Alessandro Manzoni
Lecco, 23900, Italy
Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
Meldola, 47014, Italy
Irccs Ospedale San Raffaele-UO Ginecologia
Milan, 20132, Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
Milan, 20133, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Istituto Oncologico Veneto IRCCS
Padua, 35128, Italy
Azienda Ospedaliero Universitaria Pisana, Ospedale Santa Chiara
Pisa, 56126, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 168, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Rome, 00 144, Italy
AOU Città della Salute e della Scienza di Torino - Presidio Sant'Anna
Torino, 10126, Italy
A.O. Ordine Mauriziano di Torino
Torino, 10128, Italy
Chiba Cancer Center
Chiba, 260-8717, Japan
The Jikei University Kashiwa Hospital
Chiba, 277-8567, Japan
Hyogo Cancer Center
Hyōgo, 673-8558, Japan
St. Marianna University Hospital
Kanagawa, 216-8511, Japan
Mie University Hospital
Mie, 514-8507, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Saitama Medical University International Medical Center
Saitama, 350-1241, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
The Cancer Institute Hospital Of JFCR
Tokyo, 135-8550, Japan
Szpitale Pomorskie Sp. z o.o.
Gdynia, 81-519, Poland
Uniwersyteckie Centrum Kliniczne SUM
Katowice, 50-752, Poland
Oddział Ginekologii Onkologicznej Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569, Poland
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
Siedlce, 08-110, Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, 53-413, Poland
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Keimyung University Dongsan Medical Center
Dalseo-gu, 41931, South Korea
National Cancer Center - Korea
Goyang-si, 10408, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Severance Hospital
Seoul, 0, South Korea
Complexo Hospitalario Universitario A Coruna
A Coruña, 15007, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Ciudad de Jaen
Jaén, 23007, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28009, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 2910, Spain
Hospital Universitari Son Espases
Palma, 07120, Spain
Hospital Parc Taulí
Sabadell, 08208, Spain
Hospital Universitario Donostia
San Sebastián, 20014, Spain
Hospital Universitario La Fe - Valencia
Valencia, 46026, Spain
Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Mackay Memorial Hospital
Taipei, 104, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan
Birmingham Heartlands Hospital
Birmingham, B75 7RR, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
Related Publications (1)
Eskander RN, Corr B, Cibula D, Tan DSP, Cloven N, Guerra E, Hasegawa K, Myers T, You B, Makker V, Zagouri F, Gien LT, Bartoletti M, Mallen A, Woelber L, Mocci S, Komatsubara K, Ma L, Colombo N. A randomized, phase III study of sacituzumab govitecan versus treatment of the physician's choice in patients with endometrial cancer after platinum-based chemotherapy and immunotherapy: the ASCENT-GYN-01 study (GOG-3104/ENGOT-en26/APGOT-EN2). Int J Gynecol Cancer. 2025 Sep 7:102654. doi: 10.1016/j.ijgc.2025.102654. Online ahead of print.
PMID: 41073155DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2024
First Posted
July 3, 2024
Study Start
August 28, 2024
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share