Study of Sacituzumab Govitecan (IMMU-132) in Metastatic or Locally Advanced Unresectable Urothelial Cancer

Summary

Participation Requirements

Description

This is a Phase III, global, multicenter, open-label randomized controlled trial in which approximately 600 subjects with metastatic or locally advanced unresectable UC who have progressed after prior therapy with platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed deat...

This is a Phase III, global, multicenter, open-label randomized controlled trial in which approximately 600 subjects with metastatic or locally advanced unresectable UC who have progressed after prior therapy with platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy will be randomized to either sacituzumab govitecan arm or Treatment of Physician's Choice (TPC) arm. Subjects in TPC arm will have 1 of 3 standard of care (SOC) chemotherapeutic options including paclitaxel, docetaxel, and vinflunine. Subjects randomized to the sacituzumab govitecan arm will receive 10 mg/kg of sacituzumab govitecan intravenously on Day 1 and Day 8 of 21-day cycles. Those randomized to the TPC arm will have the choice of receiving paclitaxel, docetaxel, and vinflunine administered intravenously at SOC doses of 175, 75 and 320 mg/m2 respectively, on Day 1 of 21-day cycles.

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