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NCT05562830 · ClinicalTrials.gov registry record · Phase 1
A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
A Phase 1 study of Urothelial Carcinoma, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT05562830: Active Phase 1 study of Urothelial Carcinoma, sponsored by Merck Sharp & Dohme.
NCT05562830 is a Phase 1 study of Urothelial Carcinoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 48 participants, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05562830, a Phase 1 study of Urothelial Carcinoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
Study Summary
This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.
Primary Outcome
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL MK-3120
- BIOLOGICAL Zilovertamab vedotin
Study Locations (20)
Other
- Rambam Health Care Campus-Oncology ( Site 1501) - Haifa
- Rabin Medical Center-Oncology ( Site 1504) - Petah Tikva
- Sheba Medical Center-ONCOLOGY ( Site 1503) - Ramat Gan
- Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1406) - Naples
California
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045) - Orange
- University of California San Francisco ( Site 1044) - San Francisco
Region M. de Santiago
- FALP-UIDO ( Site 1151) - Santiago
- Bradford Hill ( Site 1155) - Santiago
Colorado
- Anschutz Cancer Pavilion ( Site 1017) - Aurora
Illinois
- University of Chicago Medical Center ( Site 1037) - Chicago
Indiana
- Indiana University Melvin and Bren Simon Cancer Center ( Site 1011) - Indianapolis
Missouri
- Siteman Cancer Center ( Site 1038) - St Louis
Ohio
- Cleveland Clinic-Taussig Cancer Center ( Site 1036) - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-11-16 |
| Est. Completion | 2028-06-20 |
| Phase | Phase 1 |
What the registry record for NCT05562830 still lists
NCT05562830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05562830 names 20 study sites across 15 states, led by Other, California, Region M. de Santiago.
Frequently Asked Questions
What is clinical trial NCT05562830 about?
NCT05562830 is a clinical study titled "A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)". This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease ...
What is the current status of trial NCT05562830?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2022-11-16. Estimated completion is 2028-06-20.
What conditions does trial NCT05562830 study?
This clinical trial studies the following conditions: Urothelial Carcinoma.
What interventions are being tested in trial NCT05562830?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-3120 (BIOLOGICAL), Zilovertamab vedotin (BIOLOGICAL).
Who is sponsoring clinical trial NCT05562830?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05562830 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05562830's enrollment target sits among peer trials
48 53rd of 85 higher than 33 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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