NCT05562830

A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Zilovertamab vedotin	Administered via intravenous (IV) infusion on day 1 and day 8 of Q3W cycles
BIOLOGICAL	Pembrolizumab	Administered via IV infusion on Day 1 of each 6 week cycle.
BIOLOGICAL	MK-3120	Administered as an IV infusion on Day 1, Day 15, and Day 29 of each 6 week cycle.

Timeline

• Start date: 2022-11-16
• Primary completion: 2028-06-20
• Completion: 2028-06-20
• First posted: 2022-10-03
• Last updated: 2026-04-02

Locations

28 sites across 11 countries: United States, Australia, Canada, Chile, Denmark, Israel, Italy, Netherlands, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study