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)
Phase 3 – large-scale trial before approval
Conditions:
Endometrial Cancer
Sponsor: Gilead Sciences
trial.available_in:
БГ
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).
Who can participate
Key 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
Key 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
19
Australia (1)
Canberra Hospital
Canberra , Australian Capital Territory
Brazil (1)
Clínica de Neoplasias Litoral
Itajaí
Canada (1)
Arthur J. E. Child Comprehensive Cancer Centre
Calgary
China (1)
Beijing Cancer Hospital
Beijing
Czech Republic (1)
Nemocnice AGEL, Nový Jičín a.s.
Nový Jičín
France (1)
Centre Francois Baclesse
Caen
Germany (1)
Hochtaunus Kliniken Bad Homburg
Bad Homburg
Greece (1)
Aretaeion Hospital
Athens
Hong Kong (1)
Hong Kong Sanatorium & Hospital
Happy Valley
Israel (1)
Hillel Yaffe Medical Center
Hadera
Italy (1)
SOC di Oncologia Medica e Prevenzione Oncologica Centro di Riferimento Oncologico di Aviano (CRO) IRCCS