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New vaccine-like therapy aims to keep bladder cancer from coming back

NCT ID NCT06833073

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 15, 2026 · Updated 5 times

Summary

This study tests whether adding an experimental treatment (V940) to standard BCG therapy helps people with high-risk non-muscle invasive bladder cancer live longer without their cancer returning. About 308 adults will be randomly assigned to get either V940 plus BCG or BCG alone. The goal is to see if the combination delays cancer growth or recurrence better than BCG alone.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 308 people

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

Started

Mar 2025

Expected to finish

Sep 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: \- Is an individual whose most recent TURBT was performed within 12 weeks before randomization/allocation and showed BICR-confirmed high-risk NMIBC histology Cohort A: * Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder * Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG Cohort B: * Has CIS +/-papillary non-muscle invasive UC of the bladder * Is ineligible for, or refusing, any IVESIC therapy * Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG * Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC * Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions * Has a known additional malignancy that is progressing or has required active treatment within the last 3 years * Has had a myocardial infarction within 6 months of randomization/allocation * Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation * Has received prior treatment with a cancer vaccine * Has immunodeficiency or is receiving chronic systemic steroid therapy * Has active autoimmune disease that has required systemic treatment in the last 2 years * Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU) Cohort A: * Has current active tuberculosis * Has a known history of HIV infection Cohort B: \- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ in situ carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

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

Carcinoma in situ Non-muscle invasive bladder neoplasms Urinary bladder neoplasms

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

    85 sites in 19 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

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)

    RECRUITING

    Chaidari/Athens, Attica, 124 62, Greece

  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1419AHN, Argentina

  • Associated Urological Specialists - Chicago Ridge ( Site 0139)

    RECRUITING

    Chicago Ridge, Illinois, 60415, United States

  • Azienda USL 8 di Arezzo ( Site 1203)

    RECRUITING

    Arezzo, 52100, Italy

  • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)

    RECRUITING

    Dusit, Bangkok, 10300, Thailand

  • Bordeaux University Hospital - Pellegrin ( Site 0806)

    RECRUITING

    Bordeaux, Gironde, 33076, France

  • Bradford Hill Norte ( Site 0503)

    RECRUITING

    Antofagasta, 1240000, Chile

  • Bradfordhill ( Site 0501)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • CHU Dijon Bourgogne ( Site 0802)

    RECRUITING

    Dijon, Cote-d Or, 21079, France

  • CHU de Rouen- urology ( Site 0803)

    RECRUITING

    Rouen, Haute-Normandie, 76031, France

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0204)

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603)

    RECRUITING

    Bogotá, Bogota D.C., 111321, Colombia

  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 1402)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 61-731, Poland

  • Clínica Imbanaco S.A.S ( Site 0602)

    RECRUITING

    Cali, Valle del Cauca Department, Colombia

  • Debreceni Egyetem Klinikai Kozpont ( Site 1112)

    RECRUITING

    Debrecen, 4032, Hungary

  • Erasmus MC ( Site 1300)

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • European Interbalkan Medical Center-Oncology Department ( Site 1008)

    RECRUITING

    Thessaloniki, 570 01, Greece

  • FALP ( Site 0500)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Faculty of Medicine - Khon Kaen University ( Site 3001)

    RECRUITING

    Muang, Changwat Khon Kaen, 40002, Thailand

  • Fiona Stanley Hospital ( Site 1803)

    RECRUITING

    Perth, Western Australia, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1200)

    RECRUITING

    Roma, 00168, Italy

  • Fundacion Estudios Clinicos ( Site 0304)

    RECRUITING

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0301)

    RECRUITING

    La Rioja, F5300COE, Argentina

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0410)

    RECRUITING

    São Jose Do Rio Preto, São Paulo, 15090-000, Brazil

  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0400)

    RECRUITING

    Barretos, São Paulo, 14784-400, Brazil

  • Gartnavel General Hospital ( Site 1702)

    RECRUITING

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • Genesis Healthcare-Torrance ( Site 0140)

    RECRUITING

    Torrance, California, 90503, United States

  • Genesis Research LLC ( Site 0118)

    RECRUITING

    Torrance, California, 90505, United States

  • Genesis Research, LLC ( Site 0141)

    ACTIVE_NOT_RECRUITING

    Los Alamitos, California, 90720, United States

  • Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 1116)

    RECRUITING

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506)

    RECRUITING

    Madrid, 28223, Spain

  • Henry Dunant Hospital ( Site 1005)

    RECRUITING

    Athens, Attica, 115 26, Greece

  • Herlev and Gentofte Hospital ( Site 3101)

    RECRUITING

    Herlev, Capital Region, 2730, Denmark

  • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1118)

    RECRUITING

    Eger, Heves County, 3300, Hungary

  • Hospital Clinico San Carlos... ( Site 1500)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Insular de Gran Canaria ( Site 1502)

    RECRUITING

    Las Palmas de Gran Canaria, Canary Islands, 35016, Spain

  • Hospital Italiano de Buenos Aires ( Site 0307)

    RECRUITING

    CABA, Buenos Aires, C1199ABD, Argentina

  • Hospital Militar Central Luis Arias Schereiber ( Site 0700)

    ACTIVE_NOT_RECRUITING

    Lima, 15076, Peru

  • Hospital Universitari Parc Tauli ( Site 1505)

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Hospital Universitario 12 de Octubre ( Site 1507)

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen Macarena ( Site 1504)

    RECRUITING

    Seville, 41009, Spain

  • Hospital de Clínicas de Passo Fundo ( Site 0406)

    RECRUITING

    Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

  • Hôpital Foch-Urology department ( Site 0801)

    RECRUITING

    Suresnes, Hauts-de-Seine, 92150, France

  • Hôpital Saint-Louis ( Site 0807)

    RECRUITING

    Paris, Île-de-France Region, 75010, France

  • IMAT S.A.S ( Site 0601)

    RECRUITING

    Montería, Departamento de Córdoba, 230002, Colombia

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702)

    RECRUITING

    San Isidro, Lima region, 15038, Peru

  • Instituto Alexander Fleming ( Site 0306)

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

  • Instituto de Investigaciones Clinicas Mar de Plata ( Site 0305)

    RECRUITING

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Instituto do Câncer e Transplante de Curitiba ( Site 0402)

    RECRUITING

    Curitiba, Paraná, 80510-130, Brazil

  • Istituto Nazionale Tumori Regina Elena ( Site 1201)

    RECRUITING

    Rome, Roma, 00128, Italy

  • Klinikum Stuttgart - Katharinenhospital ( Site 0909)

    RECRUITING

    Stuttgart, Baden-Wurttemberg, 70174, Germany

  • Klinikum der Universität München Großhadern ( Site 0910)

    RECRUITING

    Munich, Bavaria, 81377, Germany

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111)

    RECRUITING

    New York, New York, 10016, United States

  • Macquarie University ( Site 1801)

    RECRUITING

    Macquarie University, New South Wales, 2109, Australia

  • Marienhospital Herne ( Site 0907)

    RECRUITING

    Herne, North Rhine-Westphalia, 44625, Germany

  • Metropolitan General Hospital ( Site 1001)

    RECRUITING

    Athens, Attica, 155 62, Greece

  • Michael G Oefelein Clinical Trials ( Site 0138)

    RECRUITING

    Bakersfield, California, 93301, United States

  • MidLantic Urology ( Site 0102)

    RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • NHO Revive Research Institute, LLC ( Site 0137)

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 1401)

    COMPLETED

    Warszawa, Lesser Poland Voivodeship, 02-781, Poland

  • OHSU Knight Cancer Institute - South Waterfront ( Site 0110)

    RECRUITING

    Portland, Oregon, 97239, United States

  • ONCOCENTRO APYS ( Site 0505)

    RECRUITING

    Viña del Mar, Valparaiso, 2520598, Chile

  • Oncocentro Valdivia ( Site 0507)

    RECRUITING

    Valdivia, Los Ríos Region, 5112129, Chile

  • Oncosalud ( Site 0701)

    RECRUITING

    Lima, Lima Province, 15036, Peru

  • Oncólogos del Occidente S.A.S. - Sede Pereira ( Site 0604)

    RECRUITING

    Pereira, Risaralda Department, 661001, Colombia

  • Pontificia Universidad Catolica de Chile ( Site 0502)

    RECRUITING

    Santiago, Region M. de Santiago, 8330032, Chile

  • Promotora Médica Las Américas S.A. ( Site 0600)

    ACTIVE_NOT_RECRUITING

    Medellín, Antioquia, 050021, Colombia

  • Rijnstate ( Site 1307)

    RECRUITING

    Arnhem, Gelderland, 6815 AD, Netherlands

  • Sanatorio Parque ( Site 0300)

    RECRUITING

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Southern Urology, LLC ( Site 0145)

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • St Bartholomew s Hospital ( Site 1700)

    RECRUITING

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

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaza ( Site 1117)

    RECRUITING

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

  • Szegedi Tudomanyegyetem ( Site 1113)

    RECRUITING

    Szeged, Csongrád megye, 6725, Hungary

  • Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 1404)

    RECRUITING

    Tarnów, Lesser Poland Voivodeship, 33-100, Poland

  • Texas Oncology-Austin Central ( Site 0107)

    RECRUITING

    Austin, Texas, 78705, United States

  • The Conrad Pearson Clinic ( Site 0143)

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • The Moncton Hospital-Oncology ( Site 0200)

    RECRUITING

    Moncton, New Brunswick, E1C 6Z8, Canada

  • Torbay Hospital ( Site 1701)

    RECRUITING

    Torquay, TQ2 7AA, United Kingdom

  • TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0122)

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • USC Norris Comprehensive Cancer Center ( Site 0123)

    RECRUITING

    Los Angeles, California, 90033, United States

  • Universitaetsklinikum Halle ( Site 0902)

    RECRUITING

    Halle, Saxony-Anhalt, 06120, Germany

  • Universitaetsklinikum Jena ( Site 0903)

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • University of Missouri Health Care ( Site 0126)

    RECRUITING

    Columbia, Missouri, 65212, United States

  • University of Washington - Fred Hutchinson Cancer Center ( Site 0100)

    RECRUITING

    Seattle, Washington, 98195, United States

  • Urological Research Network ( Site 0133)

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Urology Associates ( Site 0144)

    RECRUITING

    Littleton, Colorado, 80122, United States

  • Urology Austin, PLLC ( Site 0109)

    RECRUITING

    Austin, Texas, 78759, United States

  • Urology of Virginia ( Site 0125)

    RECRUITING

    Virginia Beach, Virginia, 23462, United States

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