Endometrial CancerPhase 3ASCENT-GYN-01NCT06486441
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)
A Phase 3 study testing Sacituzumab govitecan-hziy, Doxorubicin and Paclitaxel in people with Endometrial Cancer, run by Gilead Sciences at 189 sites in 19 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Sacituzumab govitecan-hziy, Doxorubicin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 189 sitesin 19 countries
- Study dates
- 28 Aug 2024to Jun 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
189 sites in 19 countries.
189 sites in 19 countries
United States57 sites
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Roswell Park Cancer Institute
Buffalo, New York, 14263
MUSC Hollings Cancer Center
Charleston, South Carolina, 29485
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio Health Research Institute
Columbus, Ohio, 43214
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
City of Hope
Duarte, California, 91010
Florida Cancer Specialists
Fort Myers, Florida, 33901
Texas Oncology
Fort Worth, Texas, 76104
University of Florida
Gainesville, Florida, 32610
Hartford HealthCare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06102
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044
Baylor College of Medicine Medical Center
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
MidAmerica Division, Inc. c/o Research Medical Center
Kansas City, Missouri, 64132
UC San Diego Medical Center
La Jolla, California, 92093
Northwell Health Cancer Institute
Lake Success, New York, 11042
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Baptist Health Lexington
Lexington, Kentucky, 40503
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, 90048
Norton Cancer Institute
Louisville, Kentucky, 40207
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Froedtert and the Medical College of Wisconsin (MCW)
Milwaukee, Wisconsin, 53226
M Health Fairview University of Minnesota Medical Center - East Bank Hospital
Minneapolis, Minnesota, 55455
SCRI Oncology Partners
Nashville, Tennessee, 37203
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Yale University School of Medicine
New Haven, Connecticut, 06520
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Columbia University Medical Center, Herbert Irving Pavilion
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Virginia Oncology Associates
Norfolk, Virginia, 23502
University of Nebraska Medical Center
Omaha, Nebraska, 68105
Stanford Women's Cancer Center
Palo Alto, California, 94304
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
University of Rochester Medical Center
Rochester, New York, 14642
Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, 55426
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System
Savannah, Georgia, 31405
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Baystate Medical Center
Springfield, Massachusetts, 01199
SUNY Upstate Medical University
Syracuse, New York, 13210
Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
Tulsa, Oklahoma, 74146
Kaiser Permanente Medical Center
Vallejo, California, 94589
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27103
China18 sites
Beijing Cancer Hospital
Beijing, 100142
The First Hospital of Jilin University
Changchun, 130021
Hunan Cancer Hospital
Changsha, 410013
West China Second Hospital of Sichuan University
Chengdu, 610041
Chongqing University Cancer Hospital
Chongqing, 400030
Guangxi Medical University Affiliated Tumor Hospital
Guangxi Zhuang Autonomous Region, 530021
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, 61020
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, 310006
Zhejiang Cancer Hospital
Hangzhou, 310022
Harbin Medical University Cancer Hospital
Harbin, 150081
Jiangxi Maternal and Child Health Hospital
Nanchang, 330006
Fudan University Shanghai Cancer Center
Shanghai, 200032
Shanghai Tenth People's Hospital
Shanghai, 200072
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022
Tongji Hospital, Tongji Medical College of HUST
Wuhan, 430030
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061
Henan Cancer Hospital
Zhengzhou, 450003
Italy13 sites
SOC di Oncologia Medica e Prevenzione Oncologica Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
Aviano, 33081
Azienda Ospedaliera Universitaria Careggi - Unita di Oncologia Ginecologica
Florence, 50134
ASST Lecco - Ospedale Alessandro Manzoni
Lecco, 23900
Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
Meldola, 47014
Irccs Ospedale San Raffaele-UO Ginecologia
Milan, 20132
Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
Milan, 20133
Istituto Europeo di Oncologia
Milan, 20141
Istituto Oncologico Veneto IRCCS
Padova, 35128
Azienda Ospedaliero Universitaria Pisana, Ospedale Santa Chiara
Pisa, 56126
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 168
Istituto Nazionale Tumori Regina Elena IRCCS
Rome, 00 144
AOU Città della Salute e della Scienza di Torino - Presidio Sant'Anna
Torino, 10126
A.O. Ordine Mauriziano di Torino
Torino, 10128
Spain11 sites
Complexo Hospitalario Universitario A Coruna
A Coruña, 15007
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario Ciudad de Jaen
Jaén, 23007
Hospital General Universitario Gregorio Maranon
Madrid, 28009
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Clinico San Carlos
Madrid, 28040
Hospital Universitario Virgen de la Victoria
Málaga, 2910
Hospital Universitari Son Espases
Palma, 07120
Hospital Parc Taulí
Sabadell, 08208
Hospital Universitario Donostia
San Sebastián, 20014
Hospital Universitario La Fe - Valencia
Valencia, 46026
Japan10 sites
Chiba Cancer Center
Chiba, 260-8717
The Jikei University Kashiwa Hospital
Chiba, 277-8567
Hyogo Cancer Center
Hyōgo, 673-8558
St. Marianna University Hospital
Kanagawa, 216-8511
Mie University Hospital
Mie, 514-8507
Okayama University Hospital
Okayama, 700-8558
Saitama Medical University International Medical Center
Saitama, 350-1241
Shizuoka Cancer Center
Shizuoka, 411-8777
National Cancer Center Hospital
Tokyo, 104-0045
The Cancer Institute Hospital Of JFCR
Tokyo, 135-8550
Brazil9 sites
Clínica de Neoplasias Litoral
Itajaí, 88301-220
Centro de Pesquisa Clínica do Hospital Moinhos de Vento
Porto Alegre, 90035001
Hospital Santa Joana Recife
Recife, 52011906
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro, 22281-100
Ensino e Terapia de Inovação Clínica AMO - ETICA
Salvador, 41950640
Instituto do Câncer do Estado de São Paulo
São Paulo, 01246-000
BP - A Beneficência Portuguesa da São Paulo / Hospital BP Mirante
São Paulo, 01321-001
DASA - Hospital 9 de Julho
São Paulo, 01409-002
AC Camargo Cancer Center (Fundação Antonio Prudente)
São Paulo, 01509-900
France8 sites
Centre Francois Baclesse
Caen, 14076
Institut Paoli Calmettes
Marseille, 13009
Centre Antoine Lacassagne
Nice, 06189
Hôpital Cochin
Paris, 75014
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69130
ICO - Centre René Gauducheau
Saint-Herblain, 44805
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Institut Gustave Roussy
Villejuif, 94805
Germany8 sites
Hochtaunus Kliniken Bad Homburg
Bad Homburg, 61352
Universitatsklinikum Dusseldorf
Düsseldorf, 40225
University Hospital Essen
Essen, 45147
Universitätsklinikum Hamburg
Hamburg, 20246
Medical School Hannover
Hanover, 30625
University Hospital Leipzig
Leipzig, 04103
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde
München, 81675
Universitätsklinikum Ulm
Ulm, 89075
Australia6 sites
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Canberra Hospital
Canberra, Australian Capital Territory, 2605
Monash Health
Clayton, Victoria, 3168
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Sir Charles Gairdner Hospital
Murdoch, Western Australia, 6150
Mater Cancer Care Centre
South Brisbane, Queensland, 4101
Canada6 sites
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, T2N 5G2
London Health Sciences Centre
London, N6A 5W9
McGill University Health Centre - Glen Site
Montreal, H4A 3J1
CIC-CHU de Québec-Université Laval- Hôpital de l'Enfant-Jésus
Québec, G1G 5X1
Sunnybrook Research Institute
Toronto, M4N 3M5
Princess Margaret Cancer Centre
Toronto, M5G 2M9
Israel6 sites
Hillel Yaffe Medical Center
Hadera, 3810101
Rambam Health Care Campus
Haifa, 3501602
Wolfson Medical Center
Holon, 58100
Hadassah Medical Center
Jerusalem, 91120
Sheba Medical Center
Ramat Gan, 52621
Sourasky T.A.M.C.
Tel Aviv, 6423906
South Korea6 sites
Keimyung University Dongsan Medical Center
Dalseo-gu, 41931
National Cancer Center - Korea
Goyang-si, 10408
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Severance Hospital
Seoul, 0
Taiwan6 sites
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
Taichung Veterans General Hospital
Taichung, 40705
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 10002
Mackay Memorial Hospital
Taipei, 104
Chang Gung Memorial Hospital, Linkou
Taoyuan City
United Kingdom6 sites
Birmingham Heartlands Hospital
Birmingham, B75 7RR
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary
Leicester, LE1 5WW
University College London Hospitals
London, NW1 2PG
East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre
Northwood, HA6 2RN
Greece5 sites
Aretaeion Hospital
Athens, 11528
MITERA hospital
Athens, 15123
Kalamata Hospital
Kalamata, 241 00
General Hospital of Patras Agios Andreas
Pátrai, 26335
St. Luke's Hospital
Thessaloniki, 55236
Poland5 sites
Szpitale Pomorskie Sp. z o.o.
Gdynia, 81-519
Uniwersyteckie Centrum Kliniczne SUM
Katowice, 50-752
Oddział Ginekologii Onkologicznej Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
Siedlce, 08-110
Dolnoslaskie Centrum Onkologii
Wroclaw, 53-413
Czechia4 sites
Nemocnice AGEL, Nový Jičín a.s.
Nový Jičín, 74101
University Hospital Ostrava
Ostrava-Poruba, 708 52
General University Hospital in Prague
Prague, 128 08
University Hospital Bulovka
Prague, 180 81
Hong Kong3 sites
Hong Kong Sanatorium & Hospital
Happy Valley, 999077
Queen Mary Hospital
Hong Kong, 999077
Prince of Wales Hospital
New Territories, 999077
Singapore2 sites
National University Hospital
Singapore, 119074
National Cancer Centre Singapore
Singapore, 168583
About this study
Official title: 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
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).
- Conditions
- Endometrial Cancer
- Being tested
- Sacituzumab govitecan-hziy, Doxorubicin, Paclitaxel
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab govitecan-hziyDrug
Also called Trodelvy™, GS-0132
Administered intravenously
DoxorubicinDrug
Also called Adriamycin
Administered intravenously
PaclitaxelDrug
Also called Taxol
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Govitecan (SG) | Experimental | Participants will receive SG at a dose of 10 mg/kg on Days 1 and 8 of a 21-day cycle. Receives: Drug: Sacituzumab govitecan-hziy |
| Treatment of Physician's Choice (TPC) | Active comparator | 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 Receives: Drug: Doxorubicin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to approximately 47 months
Secondary outcomes (9)
Objective Response Rate (ORR) as Assessed by BICR
ORR, defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by BICR per RECIST v1.1.
Measured: 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
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. The physical functioning scale range in score from 0 to 100. Higher score denote a better level of functioning (i.e. a better state of the participant).
Measured: Baseline, Week 16
PFS as Assessed by Investigator
PFS is defined as the time from the date of randomization until the date of objective PD, as assessed by investigator per RECIST v1.1, or death from any cause, whichever comes first
Measured: Up to approximately 27 months
ORR as Assessed by Investigator
ORR is defined as the percentage of participants who have achieved a CR or PR as best overall response that is confirmed ≥ 4 weeks after initial documentation of response as assessed by investigator per RECIST v1.1
Measured: Up to approximately 47 months
Duration of Response (DOR) as Assessed by BICR and Investigator
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD as assessed by BICR and investigator per RECIST v1.1, or death from any cause, whichever comes first.
Measured: Up to approximately 47 months
Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator
CBR is defined as the percentage of participants with best overall response of CR or PR that is confirmed ≥ 4 weeks after initial documentation of response or durable stable disease (SD; duration of SD ≥ 6 months from randomization to disease progression), as assessed by BICR and investigator per RECIST v1.1.
Measured: Up to approximately 47 months
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Measured: First dose date up to 30 days post last dose (Up to Up to approximately 47 months)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Measured: First dose date up to 30 days post last dose (Up to Up to approximately 47 months)
Change from baseline in Global Health Status (GHS)/Quality of Life (QoL) 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
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. Global health status score ranges from 0 to 100. Higher score denote a better level of functioning (i.e. a better state of the participant).
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start28 Aug 2024
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486441
- Sponsor's protocol ID
- GS-US-682-6769
- Other IDs
- 2024-511957-23, GOG-3104, ENGOT-en26, APGOT-EN2
- Acronym
- ASCENT-GYN-01
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Jun;36(6):102654. doi: 10.1016/j.ijgc.2025.102654. Epub 2025 Sep 7.
PubMed 41073155