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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Drug: Paclitaxel; Drug: Doxorubicin; Drug: Sacituzumab govitecan-hziy

• Study Type: Interventional
• Enrollment (Estimated): 640
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia, 2605
      • Canberra Hospital
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Cancer Care Centre
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Sir Charles Gairdner Hospital
• Brazil
  • Itajaí, Brazil, 88301-220
    • Clinica de Neoplasias Litoral
  • Porto Alegre, Brazil, 90035001
    • Centro de Pesquisa Clínica do Hospital Moinhos de Vento
  • Recife, Brazil, 52011906
    • Hospital Santa Joana Recife
  • Rio de Janeiro, Brazil, 22281-100
    • Instituto D'Or Pesquisa e Ensino
  • Salvador, Brazil, 41950640
    • Ensino E Terapia de Inovação Clínica Amo - Ética
  • São Paulo, Brazil, 01246-000
    • Instituto do Cancer do Estado de Sao Paulo
  • São Paulo, Brazil, 01321-001
    • BP - A Beneficência Portuguesa da São Paulo / Hospital BP Mirante
  • São Paulo, Brazil, 01409-002
    • DASA - Hospital 9 de Julho
  • São Paulo, Brazil, 01509-900
    • AC Camargo Cancer Center (Fundação Antonio Prudente)
• Canada
  • Calgary, Canada, T2N 5G2
    • Arthur J. E. Child Comprehensive Cancer Centre
  • London, Canada, N6A 5W9
    • London Health Sciences Centre
  • Montreal, Canada, H4A 3J1
    • McGill University Health Centre - Glen Site
  • Québec, Canada, G1G 5X1
    • CIC-CHU de Québec-Université Laval- Hôpital de l'Enfant-Jésus
  • Toronto, Canada, M5G 2M9
    • Princess Margaret Cancer Centre
  • Toronto, Canada, M4N 3M5
    • Sunnybrook Research Institute
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changsha, China, 410013
    • Hunan Cancer Hospital
  • Chengdu, China, 610041
    • West China Second Hospital of Sichuan University
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • Guangxi Zhuang Autonomous Region, China, 530021
    • Guangxi Medical University Affiliated Tumor Hospital
  • Guangzhou, China, 61020
    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310006
    • Women's Hospital School of Medicine Zhejiang University
  • Harbin, China, 150081
    • Harbin medical university cancer hospital
  • Nanchang, China, 330006
    • Jiangxi Maternal and Child Health Hospital
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shanghai, China, 200072
    • Shanghai Tenth People's Hospital
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute & Hospital
  • Wuhan, China, 430030
    • Tongji Hospital, Tongji Medical College of HUST
  • Wuhan, China, 430022
    • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Xi'an, China, 710061
    • The First Affiliated Hospital of Xian Jiaotong University
  • Zhengzhou, China, 450003
    • Henan Cancer Hospital
• Czechia
  • Nový Jičín, Czechia, 74101
    • Nemocnice AGEL, Nový Jičín a.s.
  • Ostrava-Poruba, Czechia, 708 52
    • University Hospital Ostrava
  • Prague, Czechia, 128 08
    • General University Hospital in Prague
  • Prague, Czechia, 180 81
    • University Hospital Bulovka
• France
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75014
    • Hopital Cochin
  • Pierre-Bénite, France, 69130
    • HCL - Centre Hospitalier Lyon Sud
  • Saint-Herblain, France, 44805
    • ICO - Centre René Gauducheau
  • Vandœuvre-lès-Nancy, France, 54519
    • Institut de Cancerologie de Lorraine
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Bad Homburg, Germany, 61352
    • Hochtaunus Kliniken Bad Homburg
  • Düsseldorf, Germany, 40225
    • Universitatsklinikum Dusseldorf
  • Essen, Germany, 45147
    • University Hospital Essen
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg
  • Hanover, Germany, 30625
    • Medical School Hannover
  • Leipzig, Germany, 04103
    • University Hospital Leipzig
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde
  • Ulm, Germany, 89075
    • Universitatsklinikum Ulm
• Greece
  • Athens, Greece, 11528
    • Aretaeion Hospital
  • Athens, Greece, 15123
    • Mitera Hospital
  • Kalamata, Greece, 241 00
    • Kalamata Hospital
  • Pátrai, Greece, 26335
    • General Hospital of Patras Agios Andreas
  • Thessaloniki, Greece, 55236
    • St. Luke's Hospital
• Hong Kong
  • Happy Valley, Hong Kong, 999077
    • Hong Kong Sanatorium & Hospital
  • Hong Kong, Hong Kong, 999077
    • Queen Mary Hospital
  • New Territories, Hong Kong, 999077
    • Prince of Wales Hospital
• Israel
  • Hadera, Israel, 3810101
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 3501602
    • Rambam Health Care Campus
  • Holon, Israel, 58100
    • Wolfson Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Sourasky T.A.M.C.
• Italy
  • Aviano, Italy, 33081
    • SOC di Oncologia Medica e Prevenzione Oncologica Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
  • Florence, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi - Unita di Oncologia Ginecologica
  • Lecco, Italy, 23900
    • ASST Lecco - Ospedale Alessandro Manzoni
  • Meldola, Italy, 47014
    • Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia
  • Milan, Italy, 20132
    • Irccs Ospedale San Raffaele-UO Ginecologia
  • Milan, Italy, 20133
    • Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
  • Padua, Italy, 35128
    • Istituto Oncologico Veneto IRCCS
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana, Ospedale Santa Chiara
  • Roma, Italy, 168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
  • Rome, Italy, 00 144
    • Istituto Nazionale Tumori Regina Elena Irccs
  • Torino, Italy, 10128
    • A.O. Ordine Mauriziano di Torino
  • Torino, Italy, 10126
    • AOU Città della Salute e della Scienza di Torino - Presidio Sant'Anna
• Japan
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Chiba, Japan, 277-8567
    • The Jikei University Kashiwa Hospital
  • Hyōgo, Japan, 673-8558
    • Hyogo Cancer Center
  • Kanagawa, Japan, 216-8511
    • St. Marianna University Hospital
  • Mie, Japan, 514-8507
    • Mie University Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Saitama, Japan, 350-1241
    • Saitama Medical University International Medical Center
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
• Poland
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie Sp. z o.o.
  • Katowice, Poland, 50-752
    • Uniwersyteckie Centrum Kliniczne SUM
  • Poznan, Poland, 60-569
    • Oddział Ginekologii Onkologicznej Uniwersytecki Szpital Kliniczny w Poznaniu
  • Siedlce, Poland, 08-110
    • Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
  • Wroclaw, Poland, 53-413
    • Dolnoslaskie Centrum Onkologii
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 168583
    • National Cancer Centre Singapore
• South Korea
  • Dalseo-gu, South Korea, 41931
    • Keimyung University Dongsan Medical Center
  • Goyang-si, South Korea, 10408
    • National Cancer Center - Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea
    • Severance Hospital
• Spain
  • A Coruña, Spain, 15007
    • Complexo Hospitalario Universitario A Coruña
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Jaén, Spain, 23007
    • Hospital Universitario Ciudad de Jaen
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Marañon
  • Málaga, Spain, 2910
    • Hospital Universitario Virgen de la Victoria
  • Palma, Spain, 07120
    • Hospital Universitari Son Espases
  • Sabadell, Spain, 08208
    • Hospital Parc Tauli
  • San Sebastián, Spain, 20014
    • Hospital Universitario Donostia
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe - Valencia
• Taiwan
  • Kaohsiung City, Taiwan, 813
    • Kaohsiung Veterans General Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital, Linkou
• United Kingdom
  • Birmingham, United Kingdom, B75 7RR
    • Birmingham Heartlands Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust
  • Leicester, United Kingdom, LE1 5WW
    • University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals
  • Northwood, United Kingdom, HA6 2RN
    • East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • La Jolla, California, United States, 92093
      • UC San Diego Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Cancer at Cedars-Sinai Medical Center
    • Palo Alto, California, United States, 94304
      • Stanford Women's Cancer Center
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Healthcare Cancer Institute at Hartford Hospital
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University
    • Savannah, Georgia, United States, 31405
      • Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • M Health Fairview University of Minnesota Medical Center - East Bank Hospital
    • Saint Louis Park, Minnesota, United States, 55426
      • Metro Minnesota Community Oncology Research Consortium (MMCORC)
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • MidAmerica Division, Inc. c/o Research Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Comprehensive Cancer Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Lake Success, New York, United States, 11042
      • Northwell Health Cancer Institute
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center, Herbert Irving Pavilion
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Atrium Health Wake Forest Baptist
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Cancer Institute Franz Clinic
  • Pennsylvania
    • Horsham, Pennsylvania, United States, 19044
      • Alliance Cancer Specialists, PC
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System, Perelman Center for Advanced Medicine
  • South Carolina
    • Charleston, South Carolina, United States, 29485
      • MUSC Hollings Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • SCRI Oncology Partners
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Comprehensive Cancer Center
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert and the Medical College of Wisconsin (MCW)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key 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

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacituzumab Govitecan (SG); Participants will receive SG at a dose of 10 mg/kg on Days 1 and 8 of a 21-day cycle.	Drug: Sacituzumab govitecan-hziy; Administered intravenously; Other Names: GS-0132; Trodelvy™
Active Comparator: Treatment of Physician's Choice (TPC); 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	Drug: Paclitaxel; Administered intravenously; Other Names: Taxol; Drug: Doxorubicin; Administered intravenously; Other Names: Adriamycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 47 months
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	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	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.	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.	Up to approximately 47 months
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)		First dose date up to 30 days post last dose (Up to Up to approximately 47 months)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities		First dose date up to 30 days post last dose (Up to 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).	Baseline, Week 16
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).	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Collaborators: GOG Foundation; European Network of Gynaecological Oncological Trial Groups (ENGOT); Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General 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. 2025 Sep 7:102654. doi: 10.1016/j.ijgc.2025.102654. Online ahead of print.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Taxoids; Cyclodecanes; Diterpenes; Anthracyclines; Naphthacenes; Aminoglycosides; Daunorubicin; Doxorubicin; Paclitaxel; sacituzumab govitecan
• Other Study ID Numbers: GS-US-682-6769; 2024-511957-23 (Other Identifier: European Medicines Agency); GOG-3104 (Other Identifier: The GOG Foundation); ENGOT-en26 (Other Identifier: European Network for Gynaecological Oncological Trial Groups); APGOT-EN2 (Other Identifier: Asia-Pacific Gynecologic Oncology Trials Group)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No