Last updated 13 days ago
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)
520 patients around the world
Available in Brazil, United States
Gilead Sciences
1Research sites
520Patients around the world
This study is for people with
Endometrial Cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
- 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.
Sites
Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
Recruiting
StudyASCENT-GYN-01
SponsorGilead Sciences
Study typeInterventional
Conditions
Endometrial Cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT06486441
