NCT07232602 · Merck Sharp & Dohme LLC
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)
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Francisco, California
- Chicago, Illinois
- Cleveland, Ohio
- Salt Lake City, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations