MedTrace Logo

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)

NCT05562830 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2030-06-28
Completion
2030-06-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • Denmark
  • Israel
  • Italy
  • Netherlands
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT05562830 on ClinicalTrials.gov