N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07232602

Registry updated: 2026-10-02
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • MK-3120 (Drug)
    Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle
  • EV (Drug)
    Administered via IV infusion on day 1 and day 8 of each 3-week cycle
  • Pembrolizumab (Biological)
    Administered via IV infusion on day 1 of each 3-week cycle
  • Rescue Medication (Drug)
    Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Eligibility criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically documented urothelial carcinoma (UC) that is locally advanced and unresectable or metastatic * Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy) * Must not have received prior systemic therapy for locally advanced or metastatic UC * If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy * If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load before randomization * If participant has a history of hepatitis C virus (HCV), has undetectable HCV viral load before randomization Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing * Has active keratitis or corneal ulcerations * Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention * Has a history of uncontrolled diabetes * Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage * Has active autoimmune disease that has required systemic treatment in the past 2 years * Has known additional malignancy that is progressing or has required active treatment within the past 2 years * Has known active central nervous system metastases and/or carcinomatous meningitis * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids, or has current pneumonitis/interstitial lung disease * Has an active infection requiring systemic therapy * If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has concurrent active HBV and HCV infection * Has a history of stem cell/solid organ transplant

Conditions

Bladder Cancer

Locations

  • UCSF Medical Center at Mission Bay ( Site 5044) — San Francisco, California, United States
  • University of Chicago Medical Center ( Site 5037) — Chicago, Illinois, United States
  • Memorial Sloan Kettering Cancer Center ( Site 5031) — New York, New York, United States
  • Cleveland Clinic Taussig Cancer ( Site 5036) — Cleveland, Ohio, United States
  • Huntsman Cancer Institute ( Site 5041) — Salt Lake City, Utah, United States
  • Fundación Arturo López Pérez ( 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
  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 5302) — Amsterdam, North Holland, Netherlands
  • 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
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record