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New hope for hard-to-treat bladder cancer: experimental drug combo enters human trials

NCT ID NCT05562830

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new drug called zilovertamab vedotin, alone or with the immunotherapy pembrolizumab, in 48 people with advanced bladder cancer that no longer responds to standard PD-1/L1 inhibitors. The study aims to see if the treatment is safe and can shrink tumors. It is part of a larger platform trial that can add new treatments as they become available.

What this could mean

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

Active substance
zilovertamab vedotin (a drug that targets cancer cells) with or without pembrolizumab (an immunotherapy)
What this could lead to
If successful, this could offer a new treatment option for people with advanced bladder cancer that no longer responds to standard immunotherapy.
What could go wrong
This is an early-phase trial with only 48 participants, so results may not apply broadly. The drugs may cause side effects or fail to shrink tumors.

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 48 people

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

Started

Nov 2022

Expected to finish

Feb 2029

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 and exclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed diagnosis of locally advanced/unresectable or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra. * Arm A: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease progression while on treatment or after treatment with an anti-PD-1/L1 monoclonal antibody (mAb) for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies OR disease recurrence while on treatment or after treatment with an anti-PD-1/L1 mAb for muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy. * Arm A: Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation. * Arm B: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease progression after treatment with an anti-PD-1/L1 mAb for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies; OR disease recurrence after treatment with an anti-PD-1/L1 mAb for MIUC administered as monotherapy or in combination with other checkpoint therapies \>12 months after last dose of treatment with an anti-PD-1/L1 mAb. * Arm B: Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion from a metastatic site or from a primary tumor that has become locally advanced and not previously irradiated. Exclusion Criteria: * Known additional nonurothelial malignancy that is progressing or has required active treatment within 3 years prior to study randomization/allocation. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation. * Active infection requiring systemic therapy. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. * Known history of human immunodeficiency virus (HIV). * Known history of hepatitis B or known hepatitis C virus infection.

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Urothelial carcinoma

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

    26 sites in 10 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

  • Anschutz Cancer Pavilion ( Site 1017)

    COMPLETED

    Aurora, Colorado, 80045, United States

  • Asan Medical Center ( Site 1901)

    RECRUITING

    Seoul, 05505, South Korea

  • Bradford Hill ( Site 1155)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • Cleveland Clinic-Taussig Cancer Center ( Site 1036)

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • FALP-UIDO ( Site 1151)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1408)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Hospital Clinico San Carlos ( Site 1765)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitari Vall d'Hebron ( Site 1767)

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Huntsman Cancer Institute ( Site 1041)

    RECRUITING

    Salt Lake City, Utah, 84112-5500, United States

  • Indiana University Melvin and Bren Simon Cancer Center ( Site 1011)

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1406)

    RECRUITING

    Naples, 80131, Italy

  • Memorial Sloan Kettering Cancer Center ( Site 1031)

    RECRUITING

    New York, New York, 10065, United States

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1302)

    RECRUITING

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Princess Margaret Cancer Centre ( Site 1106)

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1201)

    RECRUITING

    London, London, City of, SW3 6JJ, United Kingdom

  • Rabin Medical Center-Oncology ( Site 1504)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology ( Site 1501)

    RECRUITING

    Haifa, 3109601, Israel

  • Rigshospitalet-Dept. of Oncology ( Site 1701)

    RECRUITING

    Copenhagen, Capital Region, 2100, Denmark

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 1952)

    COMPLETED

    Brisbane, Queensland, 4029, Australia

  • Samsung Medical Center ( Site 1902)

    RECRUITING

    Seoul, 06351, South Korea

  • Severance Hospital, Yonsei University Health System ( Site 1903)

    RECRUITING

    Seoul, 03722, South Korea

  • Sheba Medical Center-ONCOLOGY ( Site 1503)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Siteman Cancer Center ( Site 1038)

    RECRUITING

    St Louis, Missouri, 63108, United States

  • St Bartholomew's Hospital ( Site 1206)

    RECRUITING

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

  • UPMC Hillman Cancer Center ( Site 1014)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of California San Francisco ( Site 1044)

    RECRUITING

    San Francisco, California, 94158, United States

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045)

    RECRUITING

    Orange, California, 92868, United States

  • University of Chicago Medical Center ( Site 1037)

    RECRUITING

    Chicago, Illinois, 60637, United States

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