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)

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).

Conditions

Endometrial Cancer

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Study Overview

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Study Details

Study overview

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).

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

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)

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University School of Medicine, New Haven, Connecticut, United States, 06520

Fort Myers

Florida Cancer Specialists MAIN, Fort Myers, Florida, United States, 33901

Indianapolis

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

Lexington

Baptist Health Lexington, Lexington, Kentucky, United States, 40503

Covington

Women's Cancer Care, Covington, Louisiana, United States, 70433

Kalamazoo

West Michigan Cancer Center, Kalamazoo, Michigan, United States, 49007

Saint Louis Park

MMCORC, Saint Louis Park, Minnesota, United States, 55426

Tulsa

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

Horsham

Alliance Cancer Specialists, PC, Horsham, Pennsylvania, United States, 19044

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2029-06