RecruitingPhase 1Phase 2NCT07232602

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 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D


Sponsor

Merck Sharp & Dohme LLC

Enrollment

55 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (KEYMAKER-U04 Substudy 04D) is testing new treatment combinations added to enfortumab vedotin and pembrolizumab for people with advanced bladder cancer (urothelial carcinoma) that has spread and cannot be removed with surgery. Enfortumab vedotin and pembrolizumab are already approved as a first-line treatment for this cancer. **You may be eligible if...** - You have advanced or metastatic urothelial (bladder) cancer confirmed by biopsy - You have not yet received systemic treatment for advanced or metastatic disease - You can provide a tumor tissue sample - If you have HIV, it is well controlled on antiviral medication - If you have hepatitis B or C, your viral load is undetectable **You may NOT be eligible if...** - You have previously received chemotherapy or other systemic therapy for metastatic bladder cancer - You have active, uncontrolled autoimmune disease - You have severe nerve damage (peripheral neuropathy) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMK-3120

Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle

DRUGEV

Administered via IV infusion on day 1 and day 8 of each 3-week cycle

BIOLOGICALPembrolizumab

Administered via IV infusion on day 1 of each 3-week cycle

DRUGRescue Medication

Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).


Locations(14)

UCSF Medical Center at Mission Bay ( Site 5044)

San Francisco, California, United States

Cleveland Clinic Taussig Cancer ( Site 5036)

Cleveland, Ohio, United States

Huntsman Cancer Institute ( Site 5041)

Salt Lake City, Utah, United States

FALP ( Site 5151)

Santiago, Region M. de Santiago, Chile

CHU de Bordeaux Hop St ANDRE ( Site 5607)

Bordeaux, Gironde, France

Rambam Health Care Campus ( Site 5501)

Haifa, Israel

Rabin Medical Center ( Site 5504)

Petah Tikva, Israel

Erasmus MC ( Site 5303)

Rotterdam, South Holland, Netherlands

Severance Hospital, Yonsei University Health System ( Site 5903)

Seoul, South Korea

Asan Medical Center ( Site 5901)

Seoul, South Korea

Samsung Medical Center ( Site 5902)

Seoul, South Korea

Hospital Universitari Vall de Hebron ( Site 5767)

Barcelona, Spain

Hospital Clinico San Carlos ( Site 5765)

Madrid, Spain

St Bartholomew s Hospital ( Site 5206)

London, London, City of, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07232602


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