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A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer (TROPiCS-04)
Gilead Sciences, Inc.
This is a randomised, open-label trial assessing overall survival with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer. The trial has an experimental arm and active comparator arm. In the experimental arm, participants will receive 10mg/kg of sacituzumab govitecan-hziy intravenously on Day 1 and Day 8 of 21-day cycles. In the active comparator arm, participants will receive the physician's choice of paclitaxel, docetaxel, or vinflunine at standard of care (SOC) doses of 175, 75, and 320 mg/m^2 respectively, every 3 weeks on Day 1 of 21-day cycles.