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)

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: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

Study Contact

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

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

Yale University School of Medicine
New Haven, Connecticut, 06520
United States
Florida Cancer Specialists MAIN
Fort Myers, Florida, 33901
United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Women's Cancer Care
Covington, Louisiana, 70433
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
MMCORC
Saint Louis Park, Minnesota, 55426
United States
Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
Tulsa, Oklahoma, 74146
United States
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Texas Oncology
Fort Worth, Texas, 76104
United States
Virginia Oncology Associates
Norfolk, Virginia, 23502
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