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)
Public ClinicalTrials.gov record NCT05845814. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT05845814
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Merck Sharp & Dohme LLC
- Industry
- Enrollment
- 390 participants
Conditions and interventions
Interventions
- Coformulated favezelimab/pembrolizumab Biological
- Coformulated vibostolimab/pembrolizumab Biological
- EV Combination Product
- Pembrolizumab Biological
Biological · Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 22, 2023
- Primary completion
- May 30, 2027
- Completion
- May 30, 2027
- Last update posted
- Sep 9, 2025
2023 – 2027
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Moores Cancer Center ( Site 3028) | La Jolla | California | 92093-0698 | — |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3045) | Orange | California | 92868 | — |
| UCSF Medical Center at Mission Bay ( Site 3044) | San Francisco | California | 94158 | — |
| Anschutz Cancer Pavilion ( Site 3017) | Aurora | Colorado | 80045 | — |
| Emory University School of Medicine ( Site 3043) | Atlanta | Georgia | 30322 | — |
| Indiana University Melvin and Bren Simon Cancer Center ( Site 3011) | Indianapolis | Indiana | 46202 | — |
| Dana-Farber Cancer Institute ( Site 3047) | Boston | Massachusetts | 02115 | — |
| Siteman Cancer Center ( Site 3038) | St Louis | Missouri | 63108 | — |
| Icahn School of Medicine at Mount Sinai ( Site 3018) | New York | New York | 10029 | — |
| Memorial Sloan Kettering Cancer Center ( Site 3031) | New York | New York | 10065 | — |
| Duke Cancer Institute ( Site 3027) | Durham | North Carolina | 27710 | — |
| Cleveland Clinic-Taussig Cancer Center ( Site 3036) | Cleveland | Ohio | 44195 | — |
| UPMC Hillman Cancer Center ( Site 3014) | Pittsburgh | Pennsylvania | 15232 | — |
| Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 3041) | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05845814, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2025 · Synced May 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05845814 live on ClinicalTrials.gov.