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Looking for participantsPhase1/Phase2

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

NCT ID: NCT07232602

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
MK-3120 (drug), EV (drug), Pembrolizumab (biological), Rescue Medication (drug)
How long the study runs
Study runs about 65 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
55
Started
2026-02-09
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for bladder cancer
  • • Phase1/Phase2 - 55 participants
  • • Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with bladder cancer

Where?

  • • London - St Bartholomew s Hospital ( Site 5206)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a substudy of the master protocol MK-3475-U04 (KEYMAKER-U04)

Bladder Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

If positive

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Has histologically documented urothelial carcinoma (UC) that is that has grown locally and unresectable or that has spread
  • ✓Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy)
  • ✓Must not have received prior treatment that goes through your whole body for that has grown locally or that has spread UC
  • ✓If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy

Who cannot take part

  • ✗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...
  • ✗Has active keratitis or corneal ulcerations
  • ✗Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory...
  • ✗Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study...
See the full 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

Where Is This Study? (1 UK site)

St Bartholomew s Hospital ( Site 5206)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442078228498

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09