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KEYMAKER-U04 Substudy 04D: New Treatments for Urothelial Cancer

This study is looking for new ways to treat urothelial cancer (UC), which is a type of bladder cancer that has spread or cannot be removed by surgery. Researchers are testing a new treatment called MK-3120 alongside the standard treatments, enfortumab vedotin (EV) and pembrolizumab. The main goals are to see if this combination is safe, how well people tolerate it, and if it helps shrink or get rid of the cancer. You might be able to join if you have locally advanced or metastatic UC and haven't received other treatments for it. The study plans to enroll about 55 people.

Study design
This is an interventional study with an unclear phase, planning to enroll 55 participants. It is a substudy of a larger research program.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for up to approximately 27 months and for treatment discontinuation due to adverse events for up to approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07232602

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
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~55 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:MK-3120EVPembrolizumabRescue Medication

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience an Adverse Event (AE)
Measured over Up to approximately 27 months
+3 more outcomes measured

Conditions

Bladder Cancer

Explore related trials

Urothelial Carcinoma

Where it's being run

16 sites across 12 states
South Korea3
Israel2
Spain2
California1
Illinois1
Ohio1
Utah1
Region M. de Santiago1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants Who Experience an Adverse Event (AE)Up to approximately 27 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.

  • Number of Participants Who Experience a Dose Limiting Toxicity (DLT)Up to approximately 21 days

    DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next treatment. The number of participants who experience a DLT as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 will be presented.

  • Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 24 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.

  • Objective Response Rate (ORR) as Assessed by InvestigatorUp to approximately 58 months

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Investigator will be presented.