A Randomized, Open-Label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physicians Choice in Participants with Endometrial Cancer Who Have Received Prior Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy.
Primary:
- To compare the effect of sacituzumab govitecan (SG) relative to treatment of physicians choice (TPC) on progression-free survival (PFS) as assessed by blinded independent central review (BICR).
- To compare the effect of SG relative to TPC on overall survival (OS).
Secondary:
To compare the effect of SG relative to TPC on the following:
- PFS as assessed by investigator
- ORR as assessed by investigator
- Duration of response (DOR) as assessed by BICR and investigator
- Clinical benefit rate (CBR) as assessed by BICR and investigator.
- To evaluate the safety and tolerability of SG relative to TPC.
- To compare the effect of SG relative to TPC on Global Health Status (GHS)/quality of life (QoL).
PACLITAXEL
Sacitzumab govitecan/IMMU-132
- RWJBarnabas Health
- Community Medical Center
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Rutgers University
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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