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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 · View on ClinicalTrials.gov ↗
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 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 on coformulated favezelimab/pembrolizumab plus EV and/or coformulated vibostolimab/pembrolizumab plus EV compared with pembrolizumab plus EV, after evaluation of the totality of data, the sponsor might consider Part 2 (expansion) to further characterize the efficacy and safety of the treatment arms under study.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Coformulated favezelimab/pembrolizumab
- BIOLOGICAL Coformulated vibostolimab/pembrolizumab
- COMBINATION_PRODUCT EV
Study Locations (20)
California
- Moores Cancer Center ( Site 3028) — La Jolla
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3045) — Orange
- UCSF Medical Center at Mission Bay ( Site 3044) — San Francisco
Ontario
- The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 3105) — Ottawa
- Sunnybrook Research Institute - Odette Cancer Centre ( Site 3108) — Toronto
- Princess Margaret Cancer Centre ( Site 3106) — Toronto
New York
- Icahn School of Medicine at Mount Sinai ( Site 3018) — New York
- Memorial Sloan Kettering Cancer Center ( Site 3031) — New York
Colorado
- Anschutz Cancer Pavilion ( Site 3017) — Aurora
Georgia
- Emory University School of Medicine ( Site 3043) — Atlanta
Indiana
- Indiana University Melvin and Bren Simon Cancer Center ( Site 3011) — Indianapolis
Massachusetts
- Dana-Farber Cancer Institute ( Site 3047) — Boston
Missouri
- Siteman Cancer Center ( Site 3038) — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2023-06-23 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05845814
The ClinicalTrials.gov registry entry for NCT05845814 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 4 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05845814 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Ontario, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05845814 about?
NCT05845814 is a clinical study titled "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)". 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 pe...
What is the current status of trial NCT05845814?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 390 participants. The study started on 2023-06-23. Estimated completion is 2027-05-31.
What conditions does trial NCT05845814 study?
This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Urothelial Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05845814?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Coformulated favezelimab/pembrolizumab (BIOLOGICAL), Coformulated vibostolimab/pembrolizumab (BIOLOGICAL), EV (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05845814?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05845814 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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