BENITIONSClinical Trial Intelligence

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

Phase 3 Completed NCT04527991

ConditionLocally Advanced or Metastatic Unresectable Urothelial Cancer
PhasePhase 3
SponsorGilead Sciences
StatusCompleted
Enrollment711 participants
InterventionsSacituzumab Govitecan-hziy, Paclitaxel, Docetaxel, Vinflunine
Start dateJan 13, 2021
Completion dateJul 4, 2025
Results postedJun 2, 2026

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).

Overall Survival (OS)

Up to 42 months · months

Sacituzumab Govitecan-hziy (SG)10.3 months
Treatment of Physician's Choice9.0 months
p-value0.0870
Stratified Hazard Ratio0.86 (95% CI 0.73–1.02)

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