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 Sex
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 4119403, Arkansas 4099753 72205

City of Hope
Duarte 5344147, California 5332921 91010

UC San Diego Medical Center
La Jolla 5363943, California 5332921 92093

Stanford Women's Cancer Center
Palo Alto 5380748, California 5332921 94304

Kaiser Permanente Medical Center
Vallejo 5405380, California 5332921 94589

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora 5412347, Colorado 5417618 80045

Hartford HealthCare Cancer Institute at Hartford Hospital
Hartford 4835797, Connecticut 4831725 06102

Yale University School of Medicine
New Haven 4839366, Connecticut 4831725 06520

Florida Cancer Specialists
Fort Myers 4155995, Florida 4155751 33901

University of Florida
Gainesville 4156404, Florida 4155751 32610

Baptist MD Anderson Cancer Center
Jacksonville 4160021, Florida 4155751 32207

Tampa General Hospital (Cancer Institute)
Tampa 4174757, Florida 4155751 33606

Winship Cancer Institute, Emory University
Atlanta 4180439, Georgia 4197000 30322

Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System
Savannah 4221552, Georgia 4197000 31405

Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637

Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis 4259418, Indiana 4921868 46202

Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503

Norton Cancer Institute
Louisville 4299276, Kentucky 6254925 40207

Women's Cancer Care
Covington 4321005, Louisiana 4331987 70433

Ochsner Clinic Foundation
New Orleans 4335045, Louisiana 4331987 70121

Greater Baltimore Medical Center
Baltimore 4347778, Maryland 4361885 21204

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Baystate Medical Center
Springfield 4951788, Massachusetts 6254926 01199

West Michigan Cancer Center
Kalamazoo 4997787, Michigan 5001836 49007

M Health Fairview University of Minnesota Medical Center - East Bank Hospital
Minneapolis 5037649, Minnesota 5037779 55455

Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park 5045021, Minnesota 5037779 55426

MidAmerica Division, Inc. c/o Research Medical Center
Kansas City 4393217, Missouri 4398678 64132

Rutgers Cancer Institute
New Brunswick 5101717, New Jersey 5101760 08901

University of New Mexico Comprehensive Cancer Center
Albuquerque 5454711, New Mexico 5481136 87131

Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638 14263

Northwell Health Cancer Institute
Lake Success 5123853, New York 5128638 11042

Columbia University Medical Center, Herbert Irving Pavilion
New York 5128581, New York 5128638 10032

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065

SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13210

Atrium Health Wake Forest Baptist
Winston-Salem 4499612, North Carolina 4482348 27103

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195

Ohio Health Research Institute
Columbus 4509177, Ohio 5165418 43214

Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
Tulsa 4553433, Oklahoma 4544379 74146

Providence Cancer Institute Franz Clinic
Portland 5746545, Oregon 5744337 97213

Alliance Cancer Specialists, PC
Horsham 5194302, Pennsylvania 6254927 19044

University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia 4560349, Pennsylvania 6254927 19104

MUSC Hollings Cancer Center
Charleston 4574324, South Carolina 4597040 29485

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390

Texas Oncology
Fort Worth 4691930, Texas 4736286 76104

Baylor College of Medicine Medical Center
Houston 4699066, Texas 4736286 77030

University of Virginia Comprehensive Cancer Center
Charlottesville 4752031, Virginia 6254928 22908

Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109

University of Wisconsin Carbone Cancer Center
Madison 5261457, Wisconsin 5279468 53792

Froedtert and the Medical College of Wisconsin (MCW)
Milwaukee 5263045, Wisconsin 5279468 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