Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)
NCT07232602 · View on ClinicalTrials.gov ↗
Study Summary
Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab. The goals of this study are to learn about: * The safety of the study treatment when given with standard treatment and if people tolerate it * The number of people who have the cancer respond (cancer gets smaller or goes away) with the new study treatment when given with standard treatment.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG MK-3120
- DRUG EV
- DRUG Rescue Medication
Study Locations (11)
Other
- Rambam Health Care Campus ( Site 5501) — Haifa
- Rabin Medical Center ( Site 5504) — Petah Tikva
- Severance Hospital, Yonsei University Health System ( Site 5903) — Seoul
- Asan Medical Center ( Site 5901) — Seoul
- Samsung Medical Center ( Site 5902) — Seoul
- Hospital Universitari Vall de Hebron ( Site 5767) — Barcelona
- Hospital Clinico San Carlos ( Site 5765) — Madrid
California
- UCSF Medical Center at Mission Bay ( Site 5044) — San Francisco
Ohio
- Cleveland Clinic Taussig Cancer ( Site 5036) — Cleveland
Utah
- Huntsman Cancer Institute ( Site 5041) — Salt Lake City
Gironde
- CHU de Bordeaux Hop St ANDRE ( Site 5607) — Bordeaux
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2026-02-09 |
| Est. Completion | 2030-10-18 |
| 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 NCT07232602
The ClinicalTrials.gov registry entry for NCT07232602 describes a study currently listed as 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 55 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 Bladder Cancer 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: NCT07232602 reports 11 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Ohio. 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 NCT07232602 about?
NCT07232602 is a clinical study titled "KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)". Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab. The goals of this study are to learn about: * The safety of the...
What is the current status of trial NCT07232602?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2026-02-09. Estimated completion is 2030-10-18.
What conditions does trial NCT07232602 study?
This clinical trial studies the following conditions: Bladder Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07232602?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-3120 (DRUG), EV (DRUG), Rescue Medication (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07232602?
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 NCT07232602 being conducted?
This trial has 11 study locations across California, Ohio, Utah, Gironde. 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.