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First received: April 26, 2023

Clinical Trial: A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)

Study Status: Completed

Recruit Status: RECRUITING

Condition: Metastatic Urothelial Carcinoma

Study Type: INTERVENTIONAL


Official Title: A Phase 1/2 Randomized, Umbrella Study to Evaluate the Safety and Efficacy of Pembrolizumab Plus Enfortumab Vedotin (EV) in Combination With Investigational Agents Versus Pembrolizumab Plus EV, a

Brief 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 efficacy and safety of coformulated favezelimab/pembrolizumab plus EV and coformulated vibostolimab/pembrolizumab plus EV relative to pembrolizumab plus EV.There will be no comparison of coformulated favezelimab/pembrolizumab plus EV versus coformulated vibostolimab/pembrolizumab plus EV.If ORR and/or DRR are substantially better…

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