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Clinical Trials in the UK / NCT06486441
Active, not recruiting Phase 3

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)

NCT06486441 · tracked via the Priya Life Science UK tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2024-08-28
Last updated
2026-07-29

Condition(s) studied

Endometrial Cancer

Investigational drug(s) / intervention(s)

Sacituzumab govitecan-hziyDoxorubicinPaclitaxel

Sacituzumab govitecan-hziy: Administered intravenously

Doxorubicin: Administered intravenously

Paclitaxel: Administered intravenously

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

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (189)

FacilityCityRegionStatus
University of Arkansas for Medical Sciences Little Rock Arkansas
City of Hope Duarte California
UC San Diego Medical Center La Jolla California
Cedars-Sinai Cancer at Cedars-Sinai Medical Center Los Angeles California
Stanford Women's Cancer Center Palo Alto California
Kaiser Permanente Medical Center Vallejo California
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) Aurora Colorado
Hartford HealthCare Cancer Institute at Hartford Hospital Hartford Connecticut
Yale University School of Medicine New Haven Connecticut
Florida Cancer Specialists Fort Myers Florida
University of Florida Gainesville Florida
Baptist MD Anderson Cancer Center Jacksonville Florida
Winship Cancer Institute, Emory University Atlanta Georgia
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System Savannah Georgia
Northwestern Memorial Hospital Chicago Illinois
University of Chicago Medical Center Chicago Illinois
Indiana University Melvin and Bren Simon Comprehensive Cancer Center Indianapolis Indiana
Baptist Health Lexington Lexington Kentucky
Norton Cancer Institute Louisville Kentucky
Ochsner Clinic Foundation New Orleans Louisiana
Greater Baltimore Medical Center Baltimore Maryland
Tufts Medical Center Boston Massachusetts
Massachusetts General Hospital Boston Massachusetts
Baystate Medical Center Springfield Massachusetts
West Michigan Cancer Center Kalamazoo Michigan
M Health Fairview University of Minnesota Medical Center - East Bank Hospital Minneapolis Minnesota
Metro Minnesota Community Oncology Research Consortium (MMCORC) Saint Louis Park Minnesota
University of Mississippi Medical Center Jackson Mississippi
MidAmerica Division, Inc. c/o Research Medical Center Kansas City Missouri
University of Nebraska Medical Center Omaha Nebraska
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
Rutgers Cancer Institute New Brunswick New Jersey
University of New Mexico Comprehensive Cancer Center Albuquerque New Mexico
Roswell Park Cancer Institute Buffalo New York
Northwell Health Cancer Institute Lake Success New York
Columbia University Medical Center, Herbert Irving Pavilion New York New York
Memorial Sloan Kettering Cancer Center New York New York
University of Rochester Medical Center Rochester New York
SUNY Upstate Medical University Syracuse New York
Atrium Health Wake Forest Baptist Winston-Salem North Carolina

+ 149 more sites — see the full list on the official registry below.

More Gilead Sciences trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06486441 on ClinicalTrials.gov ↗ ← All trials in the UK