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)

Purpose

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).

Condition

  • Endometrial Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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:
    • Trodelvy™
    • GS-0132
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: Doxorubicin
    Administered intravenously
    Other names:
    • Adriamycin
  • Drug: Paclitaxel
    Administered intravenously
    Other names:
    • Taxol

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205

City of Hope
Duarte, California 91010

UC San Diego Medical Center
La Jolla, California 92093

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado 80045

Yale University School of Medicine
New Haven, Connecticut 06520

Florida Cancer Specialists
Fort Myers, Florida 33901

Tampa General Hospital (Cancer Institute)
Tampa, Florida 33606

Winship Cancer Institute, Emory University
Atlanta, Georgia 30322

Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System
Savannah, Georgia 31405

Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202

Baptist Health Lexington
Lexington, Kentucky 40503

Norton Cancer Institute
Louisville, Kentucky 40207

Women's Cancer Care
Covington, Louisiana 70433

Greater Baltimore Medical Center
Baltimore, Maryland 21204

Tufts Medical Center
Boston, Massachusetts 02111

Massachusetts General Hospital
Boston, Massachusetts 02114

Baystate Medical Center
Springfield, Massachusetts 01199

West Michigan Cancer Center
Kalamazoo, Michigan 49007

M Health Fairview University of Minnesota Medical Center - East Bank Hospital
Minneapolis, Minnesota 55455

Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota 55426

Rutgers Cancer Institute
New Brunswick, New Jersey 08901

University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico 87131

Northwell Health Cancer Institute
Lake Success, New York 11042

Cleveland Clinic
Cleveland, Ohio 44195

Ohio Health Research Institute
Columbus, Ohio 43214

Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
Tulsa, Oklahoma 74146

Alliance Cancer Specialists, PC
Horsham, Pennsylvania 19044

University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104

SCRI Oncology Partners
Nashville, Tennessee 37203

Texas Oncology
Fort Worth, Texas 76104

Baylor College of Medicine Medical Center
Houston, Texas 77030

University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia 22908

Virginia Oncology Associates
Norfolk, Virginia 23502

Fred Hutchinson Cancer Center
Seattle, Washington 98109

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792

Froedtert and the Medical College of Wisconsin (MCW)
Milwaukee, Wisconsin 53226

More Details

NCT ID
NCT06486441
Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com