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
Merck Sharp & Dohme LLC
55 participants
Feb 9, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle
Administered via IV infusion on day 1 and day 8 of each 3-week cycle
Administered via IV infusion on day 1 of each 3-week cycle
Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT07232602