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RECRUITING
NCT07232602
PHASE1/PHASE2

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2026-02-09

Completion Date

2030-10-18

Last Updated

2026-04-02

Healthy Volunteers

No

Conditions

Interventions

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).

Locations (12)

UCSF Medical Center at Mission Bay ( Site 5044)

San Francisco, California, United States

Cleveland Clinic Taussig Cancer ( Site 5036)

Cleveland, Ohio, United States

Huntsman Cancer Institute ( Site 5041)

Salt Lake City, Utah, United States

CHU de Bordeaux Hop St ANDRE ( Site 5607)

Bordeaux, Gironde, France

Rambam Health Care Campus ( Site 5501)

Haifa, Israel

Rabin Medical Center ( Site 5504)

Petah Tikva, Israel

Erasmus MC ( Site 5303)

Rotterdam, South Holland, Netherlands

Severance Hospital, Yonsei University Health System ( Site 5903)

Seoul, South Korea

Asan Medical Center ( Site 5901)

Seoul, South Korea

Samsung Medical Center ( Site 5902)

Seoul, South Korea

Hospital Universitari Vall de Hebron ( Site 5767)

Barcelona, Spain

Hospital Clinico San Carlos ( Site 5765)

Madrid, Spain