A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)

Study Summary

This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the safety and preliminary efficacy of sacituzumab tirumotecan plus enfortumab vedotin (EV). Part 2 will be based on Part 1 results and will evaluate the efficacy, pharmacokinetics, and safety of sacituzumab tirumotecan plus EV in combination with pembrolizumab in participants with advanced urothelial carcinoma.

Conditions

Metastatic Urothelial Carcinoma Locally Advanced Urothelial Carcinoma

Interventions / Drugs

Sacituzumab tirumotecan Enfortumab Vedotin Pembrolizumab Supportive care measures

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment38 participants

Primary Completion—

Lead SponsorMerck Sharp & Dohme LLC

Data Retrieved2026-04-11 02:55:36.205892+00:00

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