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

NCT04527991 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 712

Last updated 2025-08-03

No results posted yet for this study

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

DRUG

Sacituzumab Govitecan-hziy

Administered intravenously

DRUG

Paclitaxel

Administered intravenously

DRUG

Docetaxel

Administered intravenously

DRUG

Vinflunine

Administered intravenously

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2025-07-04
Completion
2025-07-04
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04527991 on ClinicalTrials.gov