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

NCT03547973 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 827

Last updated 2026-03-16

No results posted yet for this study

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).

Conditions

  • Metastatic Urothelial Cancer

Interventions

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

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Gilead Sciences

    lead INDUSTRY

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2030-04-30
Completion
2030-04-30
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Greece
  • Italy
  • South Korea
  • Spain
  • 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 NCT03547973 on ClinicalTrials.gov