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)

Recruiting now · Phase 1/Phase 2

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID: NCT07232602
Run by: Merck Sharp & Dohme LLC
People needed: 55
Starts: 2026-02-09
Expected to finish: 2031-07-08
Last updated by the study team: 2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

UCSF Medical Center at Mission Bay ( Site 5044) — San Francisco, California, United States (enrolling)
University of Chicago Medical Center ( Site 5037) — Chicago, Illinois, United States (enrolling)
Cleveland Clinic Taussig Cancer ( Site 5036) — Cleveland, Ohio, United States (enrolling)
Huntsman Cancer Institute ( Site 5041) — Salt Lake City, Utah, United States (enrolling)
FALP ( Site 5151) — Santiago, Region M. de Santiago, Chile (enrolling)
CHU de Bordeaux Hop St ANDRE ( Site 5607) — Bordeaux, Gironde, France (enrolling)
Rambam Health Care Campus ( Site 5501) — Haifa, Israel (enrolling)
Rabin Medical Center ( Site 5504) — Petah Tikva, Israel (enrolling)
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 5302) — Amsterdam, North Holland, Netherlands (enrolling)
Erasmus MC ( Site 5303) — Rotterdam, South Holland, Netherlands (enrolling)
Severance Hospital, Yonsei University Health System ( Site 5903) — Seoul, South Korea (enrolling)
Asan Medical Center ( Site 5901) — Seoul, South Korea (enrolling)
Samsung Medical Center ( Site 5902) — Seoul, South Korea (enrolling)
Hospital Universitari Vall de Hebron ( Site 5767) — Barcelona, Spain (enrolling)
Hospital Clinico San Carlos ( Site 5765) — Madrid, Spain (enrolling)
St Bartholomew s Hospital ( Site 5206) — London, London, City of, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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