Clinical trial · Interventional
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)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Sacituzumab govitecan-hziy | Drug | Sacituzumab Govitecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sacituzumab Govitecan (SG)
- description
- Participants will receive SG at a dose of 10 mg/kg on Days 1 and 8 of a 21-day cycle.
- interventionNames
- Drug: Sacituzumab govitecan-hziy
- type
- ACTIVE_COMPARATOR
- label
- Treatment of Physician's Choice (TPC)
- description
- Participants will receive one of the following TPC, regimens determined prior to randomization. * Doxorubicin 60 mg/m\^2 IV on Day 1 of a 21-day cycle * Paclitaxel 80 mg/m\^2 IV on Days 1, 8, and 15 of a 28-day cycle
- interventionNames
- Drug: Doxorubicin
- Drug: Paclitaxel
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDEskander 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. 2026 Jun;36(6):102654. doi: 10.1016/j.ijgc.2025.102654. Epub 2025 Sep 7. PMID 41073155