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New combo therapy aims to stop bladder cancer return after surgery

NCT ID NCT06305767

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding a personalized cancer vaccine (V940) to standard immunotherapy (pembrolizumab) can prevent high-risk bladder cancer from coming back after surgery. About 230 adults with muscle-invasive bladder cancer will receive either the vaccine plus immunotherapy or a placebo plus immunotherapy. The goal is to see if the combination keeps people cancer-free longer and is safe.

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 230 people

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

Started

Mar 2024

Expected to finish

Oct 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 a histological diagnosis of urothelial carcinoma (UC) * Must provide blood samples per protocol, to enable intismeran autogene production, and circulating tumor deoxyribonucleic acid testing * Has an Eastern Cooperative Oncology Group performance status of 0 to 2 assessed within 7 days before randomization * Must provide a formalin-fixed paraffin-embedded tumor tissue sample for next generation sequencing Adjuvant Cohort: * Has MIUC * Has high-risk pathologic disease after radical resection * For participants who have not received cisplatin-based neoadjuvant chemotherapy, are ineligible to receive cisplatin according to protocol pre-defined criteria Perioperative Cohort: * Has MIBC * Is deemed eligible for RC and PLND and agrees to undergo curative intent standard RC and PLND and neoadjuvant and adjuvant treatment per protocol * Is ineligible to receive cisplatin according to protocol pre-defined criteria Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has known additional malignancy that is progressing or has required active treatment ≤3 years prior to study randomization * Has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has active hepatitis B and hepatitis C virus infection Adjuvant Cohort: * Has received prior systemic anticancer therapy * Has received prior neoadjuvant therapy, with the exception of neoadjuvant cisplatin-based chemotherapy for MIUC * Has severe hypersensitivity to either intismeran autogene or pembrolizumab (MK-3475) and/or any of their excipients Perioperative Cohort: * Has received any prior systemic treatment, cancer vaccine treatment, chemoradiation, and/or radiation therapy treatment for MIBC * Has severe hypersensitivity to either intismeran autogene, pembrolizumab, or EV and/or any of their excipients * Has ongoing sensory or motor neuropathy * Has active keratitis or corneal ulcerations

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 infiltrating bladder urothelial carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Bladder cancer

Contacts and locations

Locations

  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102)

    Orlando, Florida, 32804, United States

  • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1102)

    Uppsala, Uppsala County, 751 85, Sweden

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1201)

    Ankara, 06800, Turkey (Türkiye)

  • Auckland City Hospital ( Site 1901)

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli-UOSC Oncologia ( Site 0503)

    Naples, Napoli, 80131, Italy

  • BC Cancer Vancouver ( Site 0004)

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Bradfordhill-Clinical Area ( Site 1501)

    Recoleta, Santiago, Region M. de Santiago, 8420383, Chile

  • CIDO SpA ( Site 1509)

    Temuco, Araucania, 4810148, Chile

  • Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0404)

    Regensburg, Bavaria, 93053, Germany

  • Centre Hospitalier de l'Université de Montréal ( Site 0005)

    Montreal, Quebec, H2X 3E4, Canada

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0001)

    Québec, Quebec, G1J 1Z4, Canada

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002)

    Sherbrooke, Quebec, J1H 5H4, Canada

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0400)

    Berlin, 10117, Germany

  • Cleveland Clinic Main ( Site 0100)

    Cleveland, Ohio, 44195, United States

  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0805)

    Poznan, Greater Poland Voivodeship, WLK 61-731, Poland

  • Clínica Universitaria Colombia ( Site 1600)

    Bogotá, Bogota D.C., 111321, Colombia

  • Duke Cancer Institute ( Site 0107)

    Durham, North Carolina, 27710, United States

  • Ege Universitesi Hastanesi-Medical Oncology ( Site 1203)

    Izmir, 35100, Turkey (Türkiye)

  • FALP ( Site 1500)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0502)

    Milan, Lombardy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0504)

    Rome, Lazio, 00168, Italy

  • Fox Chase Cancer Center ( Site 0106)

    Philadelphia, Pennsylvania, 19111, United States

  • Fundacion Valle del Lili- CIC-Oncology CIC ( Site 1608)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Gartnavel General Hospital-Clinical Trials Unit ( Site 1301)

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • Gustave Roussy ( Site 0303)

    Villejuif, Île-de-France Region, 94805, France

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003)

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001)

    Seville, 41013, Spain

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1200)

    Ankara, 06230, Turkey (Türkiye)

  • Hopital Claude Huriez - CHU de Lille ( Site 0301)

    Lille, Nord, 59037, France

  • Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1006)

    Badalona, Barcelona, 08916, Spain

  • Hospital Militar Central Luis Arias Schereiber ( Site 1700)

    Lima, 1507, Peru

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 1002)

    Barcelona, 08035, Spain

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1005)

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Houston Methodist Hospital-Department of Urology ( Site 0111)

    Houston, Texas, 77030, United States

  • Hôpital Saint-Louis ( Site 0304)

    Paris, 75475, France

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1702)

    Lima, 15036, Peru

  • Icahn School of Medicine at Mount Sinai ( Site 0101)

    New York, New York, 10029, United States

  • Institut de Cancérologie de l'Ouest ( Site 0300)

    Angers, Maine-et-Loire, 49055, France

  • Instituto Nacional De Cancerologia-Oncología Clínica ( Site 1606)

    Bogota, Cundinamarca, 111151, Colombia

  • Karolinska Universitetssjukhuset Solna ( Site 1101)

    Stockholm, Stockholm County, 171 64, Sweden

  • Koc Universitesi Hastanesi ( Site 1206)

    Istanbul, 34025, Turkey (Türkiye)

  • Korea University Anam Hospital ( Site 2002)

    Seoul, 02841, South Korea

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 1803)

    Macquarie University, New South Wales, 2109, Australia

  • Mater Misericordiae Limited ( Site 1808)

    South Brisbane, Queensland, 4101, Australia

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 1204)

    Ankara, 06520, Turkey (Türkiye)

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 0800)

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • ONCOCENTRO APYS-ACEREY ( Site 1506)

    Viña del Mar, Valparaiso, 2520598, Chile

  • Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0802)

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

  • Oncopole Claudius Regaud ( Site 0302)

    Toulouse, Haute-Garonne, 31059, France

  • Oncosalud ( Site 1701)

    Lima, 15036, Peru

  • One Clinical Research ( Site 1807)

    Nedlands, Western Australia, 6009, Australia

  • Ospedale San Martino-U.O. Oncologia Medica 1 ( Site 0500)

    Genoa, Liguria, 16132, Italy

  • Ospedale San Raffaele-Oncologia Medica ( Site 0501)

    Milan, 20132, Italy

  • Pontificia Universidad Catolica de Chile ( Site 1503)

    Santiago, Region M. de Santiago, 832000, Chile

  • Princess Margaret Cancer Centre ( Site 0003)

    Toronto, Ontario, M5G 2M9, Canada

  • Royal Free Hospital ( Site 1300)

    London, England, NW3 2QG, United Kingdom

  • Samsung Medical Center-Urology ( Site 2001)

    Seoul, 06351, South Korea

  • Seoul National University Hospital-Urology ( Site 2000)

    Seoul, 03080, South Korea

  • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1605)

    Valledupar, Cesar Department, 200001, Colombia

  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1302)

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

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0806)

    Kielce, Świętokrzyskie Voivodeship, SWK 25-734, Poland

  • T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1205)

    Istanbul, 34147, Turkey (Türkiye)

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1202)

    Istanbul, 34722, Turkey (Türkiye)

  • The Christie NHS Foundation Trust ( Site 1306)

    Manchester, M20 4BX, United Kingdom

  • Torbay Hospital ( Site 1303)

    Torquay, Devon, TQ2 7AA, United Kingdom

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104)

    Los Angeles, California, 90095, United States

  • UT Southwestern Medical Center ( Site 0103)

    Dallas, Texas, 75390, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405)

    Dresden, Saxony, 01307, Germany

  • University of Chicago Medical Center ( Site 0109)

    Chicago, Illinois, 60637, United States

  • University of Iowa ( Site 0110)

    Iowa City, Iowa, 52242, United States

  • Universitätsklinikum Halle-Universitätsklinik und Poliklinik für Urologie ( Site 0402)

    Halle, Saxony-Anhalt, 06120, Germany

  • Westmead Hospital ( Site 1802)

    Westmead, New South Wales, 2145, Australia

  • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0401)

    Munich, Bavaria, 81675, Germany

More trials for these conditions

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