NCT07232602

KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab. The goals of this study are to learn about: * The safety of the study treatment when given with standard treatment and if people tolerate it * The number of people who have the cancer respond (cancer gets smaller or goes away) with the new study treatment when given with standard treatment.

Detailed description

This is a substudy of the master protocol MK-3475-U04 (KEYMAKER-U04)

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	MK-3120	Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle
DRUG	EV	Administered via IV infusion on day 1 and day 8 of each 3-week cycle
BIOLOGICAL	Pembrolizumab	Administered via IV infusion on day 1 of each 3-week cycle
DRUG	Rescue Medication	Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Timeline

• Start date: 2026-02-09
• Primary completion: 2030-10-18
• Completion: 2030-10-18
• First posted: 2025-11-18
• Last updated: 2026-04-13

Locations

14 sites across 8 countries: United States, Chile, France, Israel, Netherlands, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study