Status:
Coming Soon/Not Yet Recruiting
Disease Site:
Endometrial
Phase:
Official Title:
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
NCT ID:
NCT#NCT06486441
Link to Full Details:
Description:
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).
Eligibility:
Female – 18 years and older
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
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