ACTIVE_NOT_RECRUITING

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)

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Conditions

Endometrial Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-08-28
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06486441

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma).
  2. * 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.
  3. * Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator.
  4. * Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
  5. * Eastern Cooperative Oncology Group performance status score of 0 or 1.
  6. * Adequate organ function
  1. * Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded.
  2. * Participants who are candidates for curative-intent therapy at the time of study enrollment.
  3. * Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator.
  4. * Received any prior treatment with a Trop-2-directed antibody-drug conjugate (ADC).
  5. * Have an active second malignancy.
  6. * Have an active serious infection requiring systemic antimicrobial therapy.
  7. * Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months prior to randomization.
  8. * Have a positive serum pregnancy test or are breastfeeding for participants who are assigned female at birth.

Contacts and Locations

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
City of Hope
Duarte, California, 91010
United States
UC San Diego Medical Center
La Jolla, California, 92093
United States
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Stanford Women's Cancer Center
Palo Alto, California, 94304
United States
Kaiser Permanente Medical Center
Vallejo, California, 94589
United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045
United States
Hartford HealthCare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06102
United States
Yale University School of Medicine
New Haven, Connecticut, 06520
United States
Florida Cancer Specialists
Fort Myers, Florida, 33901
United States
University of Florida
Gainesville, Florida, 32610
United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
United States
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System
Savannah, Georgia, 31405
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Norton Cancer Institute
Louisville, Kentucky, 40207
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
M Health Fairview University of Minnesota Medical Center - East Bank Hospital
Minneapolis, Minnesota, 55455
United States
Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, 55426
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
MidAmerica Division, Inc. c/o Research Medical Center
Kansas City, Missouri, 64132
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Northwell Health Cancer Institute
Lake Success, New York, 11042
United States
Columbia University Medical Center, Herbert Irving Pavilion
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27103
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Ohio Health Research Institute
Columbus, Ohio, 43214
United States
Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
Tulsa, Oklahoma, 74146
United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
United States
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044
United States
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States
MUSC Hollings Cancer Center
Charleston, South Carolina, 29485
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Texas Oncology
Fort Worth, Texas, 76104
United States
Baylor College of Medicine Medical Center
Houston, Texas, 77030
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22908
United States
Virginia Oncology Associates
Norfolk, Virginia, 23502
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
United States
Froedtert and the Medical College of Wisconsin (MCW)
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28
Study Completion Date2029-06

Study Record Updates

Study Start Date2024-08-28
Study Completion Date2029-06

Terms related to this study

Additional Relevant MeSH Terms

  • Endometrial Cancer