A randomized, phase III study of sacituzumab govitecan versus treatment of the physician's choice in patients with endometrial cancer after platinum-based chemotherapy and immunotherapy: the ASCENT-GYN-01 study (GOG-3104/ENGOT-en26/APGOT-EN2)
Author Department
Ob/Gyn
Document Type
Article, Peer-reviewed
Publication Date
9-2025
Abstract
Background: Patients with recurrent or metastatic endometrial cancer who have progressed on or after platinum-based chemotherapy and PD-(L)1 inhibitor therapy have limited treatment options and a poor prognosis. Sacituzumab govitecan is a trophoblast cell-surface antigen 2-directed antibody-drug conjugate approved for certain types of breast cancer. In the phase II TROPiCS-03 trial, sacituzumab govitecan demonstrated encouraging efficacy and manageable safety in heavily pretreated patients with advanced or metastatic endometrial cancer.
Primary objective(s): The ASCENT-GYN-01 trial aims to assess the efficacy and safety of sacituzumab govitecan versus treatment of the physician's choice in patients with endometrial cancer who have received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The primary objective is to compare the effect of sacituzumab govitecan versus treatment of the physician's choice on progression-free survival, assessed by blinded independent central review, and on overall survival.
Study hypothesis: Patients with pretreated recurrent or persistent endometrial cancer will have improved progression-free survival and overall survival with sacituzumab govitecan compared with treatment of the physician's choice.
Trial design: ASCENT-GYN-01 (ClinicalTrials.gov identifier NCT06486441) is a randomized, open-label, global phase III study. Patients will be randomized in a 1:1 ratio to receive sacituzumab govitecan or treatment of the physician's choice (doxorubicin or paclitaxel).
Major inclusion/exclusion criteria: Patients aged 18 years and older with documented evidence of recurrent or persistent endometrial cancer (endometrial carcinoma or carcinosarcoma) will be enrolled. Up to 3 prior lines of systemic therapy for endometrial cancer are allowed, including platinum-based chemotherapy and PD-(L)1 inhibitor therapy, either in combination or separately. Key exclusion criteria include uterine leiomyosarcoma or endometrial stromal sarcomas and prior treatment with a trophoblast cell-surface antigen 2-directed antibody-drug conjugate or topoisomerase I inhibitor.
Primary endpoint(s): Dual primary endpoints are progression-free survival assessed by blinded independent central review and overall survival.
Sample size: Approximately 640 patients.
Estimated dates for completing accrual and presenting results: June 2029.
Trial registration: NCT06486441; GOG-3104; ENGOT-en26; APGOT-EN2.
Keywords: ASCENT-GYN-01; Endometrial Cancer; Immunotherapy; Platinum-Based Chemotherapy; Sacituzumab Govitecan.
Recommended Citation
Eskander RN, Corr B, Cibula D, Tan DSP, Cloven N, Guerra E, Hasegawa K, Myers T, You B, Makker V, Zagouri F, Gien LT, Bartoletti M, Mallen A, Woelber L, Mocci S, Komatsubara K, Ma L, Colombo N. A randomized, phase III study of sacituzumab govitecan versus treatment of the physician's choice in patients with endometrial cancer after platinum-based chemotherapy and immunotherapy: the ASCENT-GYN-01 study (GOG-3104/ENGOT-en26/APGOT-EN2). Int J Gynecol Cancer. 2025 Sep 7:102654. doi: 10.1016/j.ijgc.2025.102654. Epub ahead of print.
PMID
41073155