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NCT06833073From ClinicalTrials.govRecruiting

A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)

A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)

  • Urinary Bladder Neoplasms
  • Non-Muscle Invasive Bladder Neoplasms
  • Carcinoma in Situ

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
308
Started
11 March 2025
Main results due
3 September 2031
Study sites
89
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder.

The standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer.

The goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.

Study sites(89)

  • Michael G Oefelein Clinical Trials ( Site 0138)

    Bakersfield, California, United States

    Recruiting

  • Genesis Research, LLC ( Site 0141)

    Los Alamitos, California, United States

    Active, not recruiting

  • USC Norris Comprehensive Cancer Center ( Site 0123)

    Los Angeles, California, United States

    Recruiting

  • Genesis Healthcare-Torrance ( Site 0140)

    Torrance, California, United States

    Recruiting

  • Genesis Research LLC ( Site 0118)

    Torrance, California, United States

    Recruiting

  • Urology Associates ( Site 0144)

    Littleton, Colorado, United States

    Recruiting

  • Urological Research Network ( Site 0133)

    Hialeah, Florida, United States

    Recruiting

  • Associated Urological Specialists - Chicago Ridge ( Site 0139)

    Chicago Ridge, Illinois, United States

    Recruiting

  • Southern Urology, LLC ( Site 0145)

    Lafayette, Louisiana, United States

    Recruiting

  • University of Missouri Health Care ( Site 0126)

    Columbia, Missouri, United States

    Recruiting

  • NHO Revive Research Institute, LLC ( Site 0137)

    Lincoln, Nebraska, United States

    Recruiting

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

    New York, New York, United States

    Recruiting

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

    Cincinnati, Ohio, United States

    Recruiting

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

    Portland, Oregon, United States

    Recruiting

  • MidLantic Urology ( Site 0102)

    Bala-Cynwyd, Pennsylvania, United States

    Recruiting

  • The Conrad Pearson Clinic ( Site 0143)

    Germantown, Tennessee, United States

    Recruiting

  • Texas Oncology-Austin Central ( Site 0107)

    Austin, Texas, United States

    Recruiting

  • Urology Austin, PLLC ( Site 0109)

    Austin, Texas, United States

    Recruiting

  • Urology of Virginia ( Site 0125)

    Virginia Beach, Virginia, United States

    Recruiting

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

    Seattle, Washington, United States

    Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0307)

    CABA, Buenos Aires, Argentina

    Recruiting

  • Instituto Alexander Fleming ( Site 0306)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

    Recruiting

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

    Mar del Plata, Buenos Aires, Argentina

    Recruiting

  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)

    Buenos Aires, Buenos Aires F.D., Argentina

    Recruiting

  • Fundacion Estudios Clinicos ( Site 0304)

    Rosario, Santa Fe Province, Argentina

    Recruiting

  • Sanatorio Parque ( Site 0300)

    Rosario, Santa Fe Province, Argentina

    Recruiting

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

    La Rioja, Argentina

    Recruiting

  • Macquarie University ( Site 1801)

    Macquarie University, New South Wales, Australia

    Recruiting

  • Fiona Stanley Hospital ( Site 1803)

    Perth, Western Australia, Australia

    Recruiting

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

    Curitiba, Paraná, Brazil

    Recruiting

  • Hospital de Clínicas de Passo Fundo ( Site 0406)

    Passo Fundo, Rio Grande do Sul, Brazil

    Recruiting

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

    Barretos, São Paulo, Brazil

    Recruiting

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

    São Jose Do Rio Preto, São Paulo, Brazil

    Recruiting

  • The Moncton Hospital-Oncology ( Site 0200)

    Moncton, New Brunswick, Canada

    Recruiting

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

    Sherbrooke, Quebec, Canada

    Recruiting

  • Oncocentro Valdivia ( Site 0507)

    Valdivia, Los Ríos Region, Chile

    Recruiting

  • FALP ( Site 0500)

    Santiago, Region M. de Santiago, Chile

    Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 0502)

    Santiago, Region M. de Santiago, Chile

    Recruiting

  • Bradfordhill ( Site 0501)

    Santiago, Region M. de Santiago, Chile

    Recruiting

  • ONCOCENTRO APYS ( Site 0505)

    Viña del Mar, Valparaiso, Chile

    Recruiting

  • Bradford Hill Norte ( Site 0503)

    Antofagasta, Chile

    Recruiting

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

    Medellín, Antioquia, Colombia

    Active, not recruiting

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

    Bogotá, Bogota D.C., Colombia

    Recruiting

  • IMAT S.A.S ( Site 0601)

    Montería, Departamento de Córdoba, Colombia

    Recruiting

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

    Pereira, Risaralda Department, Colombia

    Recruiting

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

    Cali, Valle del Cauca Department, Colombia

    Recruiting

  • Herlev and Gentofte Hospital ( Site 3101)

    Herlev, Capital Region, Denmark

    Recruiting

  • CHU Dijon Bourgogne ( Site 0802)

    Dijon, Cote-d Or, France

    Recruiting

  • Bordeaux University Hospital - Pellegrin ( Site 0806)

    Bordeaux, Gironde, France

    Recruiting

  • CHU de Rouen- urology ( Site 0803)

    Rouen, Haute-Normandie, France

    Recruiting

  • Hôpital Foch-Urology department ( Site 0801)

    Suresnes, Hauts-de-Seine, France

    Recruiting

  • Hôpital Saint-Louis ( Site 0807)

    Paris, Île-de-France Region, France

    Recruiting

  • Klinikum Stuttgart - Katharinenhospital ( Site 0909)

    Stuttgart, Baden-Wurttemberg, Germany

    Recruiting

  • Klinikum der Universität München Großhadern ( Site 0910)

    Munich, Bavaria, Germany

    Recruiting

  • Marienhospital Herne ( Site 0907)

    Herne, North Rhine-Westphalia, Germany

    Recruiting

  • Universitaetsklinikum Halle ( Site 0902)

    Halle, Saxony-Anhalt, Germany

    Recruiting

  • Universitaetsklinikum Jena ( Site 0903)

    Jena, Thuringia, Germany

    Recruiting

  • Henry Dunant Hospital ( Site 1005)

    Athens, Attica, Greece

    Recruiting

  • Metropolitan General Hospital ( Site 1001)

    Athens, Attica, Greece

    Recruiting

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)

    Chaidari/Athens, Attica, Greece

    Recruiting

Showing 60 of 89 sites — filter to narrow it down. 84 of the 89 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06833073. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) | Trialion