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New hope for bladder cancer: experimental drug joins standard combo

NCT ID NCT07232602

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study tests whether adding an experimental drug (MK-3120) to the standard treatment (enfortumab vedotin plus pembrolizumab) is safe and effective for people with advanced bladder cancer that has spread. About 55 participants will receive the new combination. Researchers will monitor side effects and measure how many patients' tumors shrink or disappear.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-3120 (an investigational drug) given with enfortumab vedotin and pembrolizumab
What this could lead to
If it works, this could lead to a more effective first-line treatment for advanced bladder cancer, potentially shrinking tumors in more patients.
What could go wrong
This is an early phase 1/2 trial with only 55 participants, so results may not apply to everyone. Adding a new drug to standard therapy also raises unknown safety risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center ( Site 5901)

    RECRUITING

    Seoul, 05505, South Korea

  • CHU de Bordeaux Hop St ANDRE ( Site 5607)

    RECRUITING

    Bordeaux, Gironde, 33075, France

  • Cleveland Clinic Taussig Cancer ( Site 5036)

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Erasmus MC ( Site 5303)

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • FALP ( Site 5151)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Hospital Clinico San Carlos ( Site 5765)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitari Vall de Hebron ( Site 5767)

    RECRUITING

    Barcelona, 08035, Spain

  • Huntsman Cancer Institute ( Site 5041)

    RECRUITING

    Salt Lake City, Utah, 84112-5550, United States

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 5302)

    RECRUITING

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Rabin Medical Center ( Site 5504)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 5501)

    RECRUITING

    Haifa, 3109601, Israel

  • Samsung Medical Center ( Site 5902)

    RECRUITING

    Seoul, 06351, South Korea

  • Severance Hospital, Yonsei University Health System ( Site 5903)

    RECRUITING

    Seoul, 03722, South Korea

  • St Bartholomew s Hospital ( Site 5206)

    RECRUITING

    London, London, City of, EC1A 7BE, United Kingdom

  • UCSF Medical Center at Mission Bay ( Site 5044)

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Chicago Medical Center ( Site 5037)

    RECRUITING

    Chicago, Illinois, 60637, United States

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