Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New cocktail of cancer drugs tested for tough bladder tumors

NCT ID NCT06483334

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage study is testing a combination of three drugs—sacituzumab tirumotecan, enfortumab vedotin, and pembrolizumab—in people with advanced bladder cancer that has spread or cannot be surgically removed. The trial has two parts: first, to find safe doses of the two-drug combo, and second, to see if adding a third drug (pembrolizumab) is safe and effective. About 38 participants will be enrolled. The main goals are to check for side effects and to see if tumors shrink.

What this could mean

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

Active substance
Sacituzumab tirumotecan (MK-2870), enfortumab vedotin (EV), and pembrolizumab (Keytruda)
What this could lead to
If this works, it could point toward a more effective treatment option for people with advanced bladder cancer that has spread or cannot be removed by surgery.
What could go wrong
This is a very early, small study (Phase 1/2) with only 38 participants. The main goal is safety, not yet proof of effectiveness. Side effects from combining these strong drugs could be significant, and the treatment may not work for everyone.

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 38 people

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

Started

Jul 2024

Expected to finish

Mar 2028

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: * Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC). * 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. A newly obtained biopsy is strongly preferred, but not required if archival tissue is evaluable. * Any AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Endocrine-related AEs adequately treated with hormone replacement are eligible. * PART 1 ONLY: Participants must have received platinum-based chemotherapy for treatment of la/mUC. * PART 1 ONLY: Participants must not have received \>2 lines of therapy for la/mUC. Platinum-based chemotherapy followed by avelumab maintenance is considered 2 lines of therapy. * PART 2 ONLY: Participants must not have received prior systemic therapy for la/mUC. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Known additional malignancy that is progressing or has required active treatment within the past 3 years. * Known active central nervous system metastases and/or carcinomatous meningitis. * Has Grade ≥2 peripheral neuropathy. * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. * 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 and/or serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention. * Has active keratitis or corneal ulcerations. Superficial punctate keratitis is allowed if the disorder is being adequately treated in the opinion of the investigator. * Has a history of uncontrolled diabetes. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. * PART 2 ONLY: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency. * PART 2 ONLY: Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy. * Is human immunodeficiency virus (HIV)-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has active Hepatitis B or Hepatitis C virus infection. * 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. * PART 2 ONLY: History of allogeneic tissue/solid organ transplant. * Has not adequately recovered from major surgery or has ongoing surgical complications.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Locally advanced urothelial carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 bladder transitional cell carcinoma infiltrating bladder urothelial carcinoma transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Locally advanced urothelial carcinoma Metastatic urothelial carcinoma

Contacts and locations

Locations

  • Asan Medical Center-Department of Oncology ( Site 4901)

    Seoul, 05505, South Korea

  • Centre Hospitalier Lyon Sud ( Site 4606)

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France

  • Cleveland Clinic-Taussig Cancer Center ( Site 4036)

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute ( Site 4047)

    Boston, Massachusetts, 02115, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 4405)

    Milan, 20133, Italy

  • Hospital Clinico San Carlos ( Site 4765)

    Madrid, 28040, Spain

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 4767)

    Barcelona, 08035, Spain

  • Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 4041)

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mount Sinai ( Site 4018)

    New York, New York, 10029, United States

  • Indiana University Melvin and Bren Simon Cancer Center ( Site 4011)

    Indianapolis, Indiana, 46202, United States

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 4406)

    Naples, 80131, Italy

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 4803)

    Tainan, 704, Taiwan

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 4302)

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Ospedale San Raffaele-Oncologia Medica ( Site 4403)

    Milan, Lombardy, 20132, Italy

  • Princess Margaret Cancer Centre ( Site 4106)

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center-Oncology ( Site 4504)

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 4501)

    Haifa, 3109601, Israel

  • Samsung Medical Center ( Site 4902)

    Seoul, 06351, South Korea

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4903)

    Seoul, 03722, South Korea

  • Sheba Medical Center-ONCOLOGY ( Site 4503)

    Ramat Gan, 5265601, Israel

  • Siteman Cancer Center ( Site 4038)

    St Louis, Missouri, 63108, United States

  • St Bartholomew s Hospital ( Site 4206)

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

  • The Ottawa Hospital - General Campus ( Site 4105)

    Ottawa, Ontario, K1H 8L6, Canada

  • University of California San Francisco HDFCCC ( Site 4044)

    San Francisco, California, 94158, United States

  • University of Chicago Medical Center ( Site 4037)

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.