Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT05562830 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05562830
The ClinicalTrials.gov registry entry for NCT05562830 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 48 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 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 3 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: NCT05562830 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, California, Region M. de Santiago. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05562830?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-3120 (BIOLOGICAL), Zilovertamab vedotin (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05562830?
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 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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.