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 (ASCENT-GYN-01)

PROTOCOL 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).

Participation requirements

Age

18 years +

Sex

FEMALE

Healthy Volunteers

Study details

Medical Condition

Endometrial Cancer

Gender

N/A

Date

August 2024 - June 2029

Study Type

Interventional

Study Phase

Phase 3

Product

Sacituzumab govitecan-hziy, Doxorubicin, Paclitaxel

Eligibility information

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.

Locations

Locations (189)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

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)

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (189)

University of Arkansas for Medical Sciences

City of Hope

UC San Diego Medical Center

Cedars-Sinai Cancer at Cedars-Sinai Medical Center

Stanford Women's Cancer Center

Kaiser Permanente Medical Center

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Hartford HealthCare Cancer Institute at Hartford Hospital

Yale University School of Medicine

Florida Cancer Specialists

University of Florida

Baptist MD Anderson Cancer Center

Winship Cancer Institute, Emory University

Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System

Northwestern Memorial Hospital

University of Chicago Medical Center

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Baptist Health Lexington

Norton Cancer Institute

Ochsner Clinic Foundation

Greater Baltimore Medical Center

Tufts Medical Center

Massachusetts General Hospital

Baystate Medical Center

West Michigan Cancer Center

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

Metro Minnesota Community Oncology Research Consortium (MMCORC)

University of Mississippi Medical Center

MidAmerica Division, Inc. c/o Research Medical Center

University of Nebraska Medical Center

Dartmouth-Hitchcock Medical Center

Rutgers Cancer Institute

University of New Mexico Comprehensive Cancer Center

Roswell Park Cancer Institute

Northwell Health Cancer Institute

Columbia University Medical Center, Herbert Irving Pavilion

Memorial Sloan Kettering Cancer Center

University of Rochester Medical Center

SUNY Upstate Medical University

Atrium Health Wake Forest Baptist

Cleveland Clinic

Ohio Health Research Institute

Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa

Providence Cancer Institute Franz Clinic

Alliance Cancer Specialists, PC

University of Pennsylvania Health System, Perelman Center for Advanced Medicine

MUSC Hollings Cancer Center

SCRI Oncology Partners

University of Texas Southwestern Medical Center

Texas Oncology

Baylor College of Medicine Medical Center

The University of Texas MD Anderson Cancer Center

University of Virginia Comprehensive Cancer Center

Virginia Oncology Associates

Fred Hutchinson Cancer Center

University of Wisconsin Carbone Cancer Center

Froedtert and the Medical College of Wisconsin (MCW)

Canberra Hospital

Chris O'Brien Lifehouse

Mater Cancer Care Centre

Monash Health

Peter MacCallum Cancer Centre

Sir Charles Gairdner Hospital

Clínica de Neoplasias Litoral

Centro de Pesquisa Clínica do Hospital Moinhos de Vento

Hospital Santa Joana Recife

Instituto D'Or Pesquisa e Ensino

Ensino e Terapia de Inovação Clínica AMO - ETICA