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Bladder cancer trial tests two new drug cocktails against standard combo

NCT ID NCT05845814

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether adding either favezelimab or vibostolimab to the standard combination of pembrolizumab and enfortumab vedotin works better for advanced bladder cancer that has spread. About 390 people who have not had prior treatment for advanced disease will take part. The main goals are to see if the new combos shrink tumors more often and to check for side effects.

What this could mean

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

Active substance
Pembrolizumab plus enfortumab vedotin, with either favezelimab or vibostolimab
What this could lead to
If successful, this could lead to a more effective first-line treatment for advanced bladder cancer, potentially shrinking tumors more often and keeping them under control longer.
What could go wrong
This is an early-phase study (phase 1/2) with a small number of participants, so results may not apply to everyone. Adding new drugs also raises the chance of side effects.

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 390 people

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

Started

Jun 2023

Expected to finish

May 2027

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: * Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC). * Participants with mixed histology are eligible provided the urothelial component is ≥50% (and \<10% plasmacytoid component) * Participants whose tumors contain any neuroendocrine component are not eligible (variant histology to be confirmed locally) * Must not have received prior systemic therapy for la/mUC. The following therapies in earlier disease setting (eg, muscle-invasive urothelial carcinoma (MIUC)) are permitted: * Participants that received neoadjuvant or adjuvant chemotherapy are permitted. * Participants who received anti- programmed cell death 1 protein (PD-1) or programmed cell death ligand 1 (PD-L1) therapy for an earlier disease stage (eg, NMIBC, MIUC) with progression/recurrence \>12 months from completion of therapy are permitted. * 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 or with \<Grade 2 neuropathy are eligible. Exclusion Criteria: * Has a known additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy. * Central nervous system (CNS) metastases are permitted on-study if all of the following are true: a) CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis; b) the participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment); c) participant does not have leptomeningeal disease. * Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior 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. * 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 an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy. * Has a history of uncontrolled diabetes. * Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis * Has an active infection (viral, bacterial, or fungal) requiring systemic therapy. * Has a known history of human immunodeficiency virus (HIV) infection. * Has hepatitis B or hepatitis C virus infection. * Has had major surgery within 4 weeks prior to first dose of study intervention. * Has had an allogenic tissue/solid organ transplant

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma urothelial carcinoma urothelial neoplasm

As listed by the trial registrant

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

Metastatic urothelial carcinoma Urothelial neoplasms

Contacts and locations

Locations

  • Anschutz Cancer Pavilion ( Site 3017)

    Aurora, Colorado, 80045, United States

  • Asan Medical Center-Department of Oncology ( Site 3901)

    Seoul, 05505, South Korea

  • Austin Health-Cancer Clinical Trials Centre ( Site 3950)

    Heidelberg, Victoria, 3084, Australia

  • Bradford Hill Norte ( Site 3152)

    Antofagasta, 1240000, Chile

  • Bradfordhill-Clinical Area ( Site 3155)

    Santiago, Region M. de Santiago, 8420383, Chile

  • CHU de Bordeaux Hop St ANDRE ( Site 3607)

    Bordeaux, Aquitaine, 33075, France

  • Centre Georges François Leclerc-Centre de recherche clinique ( Site 3608)

    Dijon, Cote-d Or, 21079, France

  • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 3802)

    Kaohsiung City, 83301, Taiwan

  • Cleveland Clinic-Taussig Cancer Center ( Site 3036)

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute ( Site 3047)

    Boston, Massachusetts, 02115, United States

  • Duke Cancer Institute ( Site 3027)

    Durham, North Carolina, 27710, United States

  • Emory University School of Medicine ( Site 3043)

    Atlanta, Georgia, 30322, United States

  • Erasmus Medisch Centrum-Medical Oncology ( Site 3303)

    Rotterdam, South Holland, 3015 GD, Netherlands

  • FALP-UIDO ( Site 3151)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3405)

    Milan, Lombardy, 20133, Italy

  • Hospital Clinico San Carlos ( Site 3765)

    Madrid, 28040, Spain

  • Hospital Universitari Vall d'Hebron ( Site 3767)

    Barcelona, Catalonia, 08035, Spain

  • Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 3041)

    Salt Lake City, Utah, 84112, United States

  • Hôpital Européen Georges Pompidou ( Site 3605)

    Paris, 75015, France

  • Icahn School of Medicine at Mount Sinai ( Site 3018)

    New York, New York, 10029, United States

  • Indiana University Melvin and Bren Simon Cancer Center ( Site 3011)

    Indianapolis, Indiana, 46202, United States

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3406)

    Naples, Campania, 80131, Italy

  • Maastricht UMC+ ( Site 3304)

    Maastricht, Limburg, 6229 HX, Netherlands

  • Memorial Sloan Kettering Cancer Center ( Site 3031)

    New York, New York, 10065, United States

  • Moores Cancer Center ( Site 3028)

    La Jolla, California, 92093-0698, United States

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 3803)

    Tainan, 704, Taiwan

  • National Taiwan University Hospital-Oncology ( Site 3801)

    Taipei, 10002, Taiwan

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 3302)

    Amsterdam, North Holland, 1066 CX, Netherlands

  • ONCOCENTRO APYS-ACEREY ( Site 3158)

    Viña del Mar, Valparaiso, 2520598, Chile

  • Oncopole Claudius Regaud ( Site 3610)

    Toulouse, Haute-Garonne, 31059, France

  • Ospedale San Raffaele-Oncologia Medica ( Site 3403)

    Milan, 20132, Italy

  • Princess Margaret Cancer Centre ( Site 3106)

    Toronto, Ontario, M5G 2M9, Canada

  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 3201)

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

  • Rabin Medical Center-Oncology ( Site 3504)

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology Division ( Site 3501)

    Haifa, 3109601, Israel

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 3951)

    Brisbane, Queensland, 4029, Australia

  • Samsung Medical Center ( Site 3902)

    Seoul, 06351, South Korea

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3903)

    Seoul, 03722, South Korea

  • Sheba Medical Center-ONCOLOGY ( Site 3503)

    Ramat Gan, 5265601, Israel

  • Siteman Cancer Center ( Site 3038)

    St Louis, Missouri, 63108, United States

  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3206)

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

  • Sunnybrook Research Institute - Odette Cancer Centre ( Site 3108)

    Toronto, Ontario, M4N 3M5, Canada

  • The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 3105)

    Ottawa, Ontario, K1H 8L6, Canada

  • UCSF Medical Center at Mission Bay ( Site 3044)

    San Francisco, California, 94158, United States

  • UPMC Hillman Cancer Center ( Site 3014)

    Pittsburgh, Pennsylvania, 15232, United States

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3045)

    Orange, California, 92868, United States

  • centre hospitalier lyon sud ( Site 3606)

    Pierre-Bénite, Rhone, 69310, France

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