Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.

Official Title

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants With PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A

Keywords

Urothelial Carcinoma, Carcinoma, Transitional Cell Carcinoma, Zilovertamab vedotin

Eligibility

Locations

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045)
    Orange California 92868 United States
  • Anschutz Cancer Pavilion ( Site 1017)
    Aurora Colorado 80045 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Protocol Plain Language Summary
ID
NCT05562830
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated