Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Gilead Sciences (Voir sur ClinicalTrials)
août 2024
juin 2029
15 septembre 2025
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Francois Baclesse - 14076 - Caen Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| HCL - Centre Hospitalier Lyon Sud - 69130 - Pierre Benite - France | Contact (sur clinicalTrials) | ||||
| ICO - Centre René Gauducheau - 44805 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de Lorraine - 54519 - Vandoeuvre Les Nancy - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
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
- 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
- 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.