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NCT07232602 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Bladder Cancer, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 11
- Study locations
NCT07232602: Recruiting Phase 1 study of Bladder Cancer, sponsored by Merck Sharp & Dohme.
NCT07232602 is a Phase 1 study of Bladder Cancer that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 55 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 11 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07232602, a Phase 1 study of Bladder Cancer, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.
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 |
What NCT07232602 shows while recruiting
NCT07232602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
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.
NCT07232602 lists 11 locations in 5 states (Other, California, Ohio).
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.
What interventions are being tested in trial NCT07232602?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-3120 (DRUG), EV (DRUG), Rescue Medication (DRUG).
Who is sponsoring clinical trial NCT07232602?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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
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Where NCT07232602's enrollment target sits among peer trials
55 107th of 175 higher than 68 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer 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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