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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).

Protocol Number: 102404
Phase: Phase III
Applicable Disease Sites: Other Female Genital
Drugs Involved: DOXORUBICIN
PACLITAXEL
Sacitzumab govitecan/IMMU-132
Principal Investigator: Aliza Leiser
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Jersey City Medical Center, Jersey City
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
  • Rutgers University
Inclusion & Exclusion Criteria

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.

For further information about clinical trials, please contact us at 732-235-7356.