# 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)

Source: https://onco.cc/trials/nct05845814/  
OnCo record `nct05845814` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Favezelimab and Pembrolizumab in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.

## Summary

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) is a phase 1/2 interventional study registered as NCT05845814 by Merck Sharp & Dohme LLC, with 390 participants enrolled, started 2023-06-23 and due to reach its primary completion in 2027-05-31. Interventions recorded: Coformulated favezelimab/pembrolizumab, Coformulated vibostolimab/pembrolizumab, EV and Pembrolizumab.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05845814
- Phase: 1/2
- Setting: 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, as First-Line Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04B
- Sponsor: Merck Sharp & Dohme LLC
- Enrolled: 390

## Sources

- ClinicalTrials.gov NCT05845814: https://clinicaltrials.gov/study/NCT05845814

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- drugs: [Favezelimab](https://onco.cc/drugs/favezelimab/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)

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