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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 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.

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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.

Conditions Studied

Bladder Cancer

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

FieldValue
Enrollment Target 55 participants
Start Date 2026-02-09
Est. Completion 2030-10-18
Phase Phase 1

Sponsor

Merck Sharp & Dohme

558 total trials

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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, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.