KEYMAKER-U04
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)
- NCT05845814 ↗
- Active, not recruiting
- Merck Sharp & Dohme LLC
- Focused
We haven't built an HCP commentary report on KEYMAKER-U04 (MK-4280A plus enfortumab vedotin; MK-7684A plus enfortumab vedotin in first-line metastatic urothelial carcinoma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on KEYMAKER-U04 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 8 |
The trial
ClinicalTrials.gov- 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, as First-Line Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04B
- Phase
- Phase 1/Phase 2
- Status
- Active, not recruiting
- Conditions
- Metastatic Urothelial Carcinoma; Urothelial Neoplasms
- Interventions
- Coformulated favezelimab/pembrolizumab; Coformulated vibostolimab/pembrolizumab; EV; Pembrolizumab
- Arms
- Arm A: Coformulated favezelimab/pembrolizumab plus EV · Experimental
- Arm B: Coformulated vibostolimab/pembrolizumab plus EV · Experimental
- Arm C: Pembrolizumab plus EV · Active comparator
- Enrollment
- 390 (estimated)
- Primary outcomes
- Part 1: Objective Response Rate (ORR)
- Part 1: Percentage of Participants experiencing an Adverse Event (AE)
- Part 1: Percentage of Participants who Discontinue study interventions due to an AE
- Part 1: Percentage of Participants with Dose-limiting toxicities (DLT)
- Part 2: Progression Free Survival (PFS)
- Sponsor
- Merck Sharp & Dohme LLC
- Start
- Jun 23, 2023
- Primary completion
- May 31, 2027 (estimated)
- Results posted
- No
- Registry record
- NCT05845814 · updated Sep 10, 2025