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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
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
MK-3120
Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle
EV
Administered via IV infusion on day 1 and day 8 of each 3-week cycle
Pembrolizumab
Administered via IV infusion on day 1 of each 3-week cycle
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