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NCT05845814 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Metastatic Urothelial Carcinoma and Urothelial Neoplasms, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 1
- Development phase
- 390
- Enrollment target
- 20
- Study locations
NCT05845814: Active Phase 1 study of Metastatic Urothelial Carcinoma and Urothelial Neoplasms, sponsored by Merck Sharp & Dohme.
NCT05845814 is a Phase 1 study of Metastatic Urothelial Carcinoma and Urothelial Neoplasms that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 390 participants, above the 118-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (231% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05845814, a Phase 1 study of Metastatic Urothelial Carcinoma and Urothelial Neoplasms, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 390 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). ORR will be reported for participants in Part 1.
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 |
What the registry record for NCT05845814 still lists
NCT05845814 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, above the 118-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (231% higher).
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.
NCT05845814 names 20 study sites across 15 states, led by California, Ontario, New York.
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.
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).
Who is sponsoring clinical trial NCT05845814?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05845814's enrollment target sits among peer trials
390 3rd of 30 higher than 28 of 30 other Metastatic Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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