NCT03547973

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 827 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).

Detailed description

Non-Randomized for Cohorts 1,2,3, and 4; Randomized for Cohorts 5, 6, and 7. Cohort 5 has been cancelled, effective December 2023.

Conditions

• Metastatic Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan-hziy	Administered intravenously.
DRUG	Pembrolizumab	Administered per package insert
DRUG	Cisplatin	Administered per package insert
DRUG	Avelumab	Administered per package insert
DRUG	Zimberelimab	Administered intravenously
DRUG	Carboplatin	Administered per package insert
DRUG	Gemcitabine	Administered per package insert
DRUG	Domvanalimab	Administered intravenously
DRUG	Enfortumab Vedotin	Administered intravenously

Timeline

• Start date: 2018-08-13
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2018-06-06
• Last updated: 2026-03-16

Locations

135 sites across 9 countries: United States, France, Germany, Greece, Italy, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study