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)
Start Date
2/9/2026
Completion Date
7/8/2031
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)
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
MK-3120
EV
Pembrolizumab
Rescue Medication
Conditions
Locations
UCSF Medical Center at Mission Bay ( Site 5044)
San Francisco, California 94158
United States
University of Chicago Medical Center ( Site 5037)
Chicago, Illinois 60637
United States
Cleveland Clinic Taussig Cancer ( Site 5036)
Cleveland, Ohio 44195
United States
Huntsman Cancer Institute ( Site 5041)
Salt Lake City, Utah 84112-5550
United States
FALP ( Site 5151)
Santiago, Region M. de Santiago 7500921
Chile
CHU de Bordeaux Hop St ANDRE ( Site 5607)
Bordeaux, Gironde 33075
France
Rambam Health Care Campus ( Site 5501)
Haifa, 3109601
Israel
Rabin Medical Center ( Site 5504)
Petah Tikva, 4941492
Israel
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 5302)
Amsterdam, North Holland 1066 CX
Netherlands
Erasmus MC ( Site 5303)
Rotterdam, South Holland 3015 GD
Netherlands
Severance Hospital, Yonsei University Health System ( Site 5903)
Seoul, 03722
South Korea
Asan Medical Center ( Site 5901)
Seoul, 05505
South Korea
Samsung Medical Center ( Site 5902)
Seoul, 06351
South Korea
Hospital Universitari Vall de Hebron ( Site 5767)
Barcelona, 08035
Spain
Hospital Clinico San Carlos ( Site 5765)
Madrid, 28040
Spain
St Bartholomew s Hospital ( Site 5206)
London, London, City of EC1A 7BE
United Kingdom