NCT04527991

Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 712 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

Conditions

• Locally Advanced or Metastatic Unresectable Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan-hziy	Administered intravenously
DRUG	Paclitaxel	Administered intravenously
DRUG	Docetaxel	Administered intravenously
DRUG	Vinflunine	Administered intravenously

Timeline

• Start date: 2021-01-13
• Primary completion: 2025-07-04
• Completion: 2025-07-04
• First posted: 2020-08-27
• Last updated: 2025-08-03

Locations

234 sites across 27 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, China, Croatia, Czechia, France, Georgia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Portugal, Puerto Rico, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study