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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT06833073

Registry updated: 2026-10-01
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Description

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.

Interventions

  • Intismeran autogene (Biological)
    IM injection
  • BCG (Biological)
    Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.

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

Conditions

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

Locations

  • Michael G Oefelein Clinical Trials ( Site 0138) — Bakersfield, California, United States
  • Genesis Research, LLC ( Site 0141) — Los Alamitos, California, United States
  • USC Norris Comprehensive Cancer Center ( Site 0123) — Los Angeles, California, United States
  • Genesis Healthcare-Torrance ( Site 0140) — Torrance, California, United States
  • Genesis Research LLC ( Site 0118) — Torrance, California, United States
  • Urology Associates ( Site 0144) — Littleton, Colorado, United States
  • Urological Research Network ( Site 0133) — Hialeah, Florida, United States
  • Associated Urological Specialists - Chicago Ridge ( Site 0139) — Chicago Ridge, Illinois, United States
  • Southern Urology, LLC ( Site 0145) — Lafayette, Louisiana, United States
  • University of Missouri Health Care ( Site 0126) — Columbia, Missouri, United States
  • NHO Revive Research Institute, LLC ( Site 0137) — Lincoln, Nebraska, United States
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111) — New York, New York, United States
  • TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0122) — Cincinnati, Ohio, United States
  • OHSU Knight Cancer Institute - South Waterfront ( Site 0110) — Portland, Oregon, United States
  • MidLantic Urology ( Site 0102) — Bala-Cynwyd, Pennsylvania, United States
  • The Conrad Pearson Clinic ( Site 0143) — Germantown, Tennessee, United States
  • Texas Oncology-Austin Central ( Site 0107) — Austin, Texas, United States
  • Urology Austin, PLLC ( Site 0109) — Austin, Texas, United States
  • Urology of Virginia ( Site 0125) — Virginia Beach, Virginia, United States
  • University of Washington - Fred Hutchinson Cancer Center ( Site 0100) — Seattle, Washington, United States
  • Hospital Italiano de Buenos Aires ( Site 0307) — CABA, Buenos Aires, Argentina
  • Instituto Alexander Fleming ( Site 0306) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
  • Instituto de Investigaciones Clinicas Mar de Plata ( Site 0305) — Mar del Plata, Buenos Aires, Argentina
  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303) — Buenos Aires, Buenos Aires F.D., Argentina
  • Fundacion Estudios Clinicos ( Site 0304) — Rosario, Santa Fe Province, Argentina
  • Sanatorio Parque ( Site 0300) — Rosario, Santa Fe Province, Argentina
  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0301) — La Rioja, Argentina
  • Macquarie University ( Site 1801) — Macquarie University, New South Wales, Australia
  • Fiona Stanley Hospital ( Site 1803) — Perth, Western Australia, Australia
  • Instituto do Câncer e Transplante de Curitiba ( Site 0402) — Curitiba, Paraná, Brazil
  • Hospital de Clínicas de Passo Fundo ( Site 0406) — Passo Fundo, Rio Grande do Sul, Brazil
  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0400) — Barretos, São Paulo, Brazil
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0410) — São Jose Do Rio Preto, São Paulo, Brazil
  • The Moncton Hospital-Oncology ( Site 0200) — Moncton, New Brunswick, Canada
  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0204) — Sherbrooke, Quebec, Canada
  • Oncocentro Valdivia ( Site 0507) — Valdivia, Los Ríos Region, Chile
  • Fundación Arturo López Pérez ( Site 0500) — Santiago, Region M. de Santiago, Chile
  • Pontificia Universidad Catolica de Chile ( Site 0502) — Santiago, Region M. de Santiago, Chile
  • Bradfordhill ( Site 0501) — Santiago, Region M. de Santiago, Chile
  • ONCOCENTRO APYS ( Site 0505) — Viña del Mar, Valparaiso, Chile
  • Bradford Hill Norte ( Site 0503) — Antofagasta, Chile
  • Promotora Médica Las Américas S.A. ( Site 0600) — Medellín, Antioquia, Colombia
  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603) — Bogotá, Bogota D.C., Colombia
  • IMAT S.A.S ( Site 0601) — Montería, Departamento de Córdoba, Colombia
  • Oncólogos del Occidente S.A.S. - Sede Pereira ( Site 0604) — Pereira, Risaralda Department, Colombia
  • Clínica Imbanaco S.A.S ( Site 0602) — Cali, Valle del Cauca Department, Colombia
  • Herlev and Gentofte Hospital ( Site 3101) — Herlev, Capital Region, Denmark
  • CHU Dijon Bourgogne ( Site 0802) — Dijon, Cote-d Or, France
  • Bordeaux University Hospital - Pellegrin ( Site 0806) — Bordeaux, Gironde, France
  • CHU de Rouen- urology ( Site 0803) — Rouen, Haute-Normandie, France
  • Hôpital Foch-Urology department ( Site 0801) — Suresnes, Hauts-de-Seine, France
  • Hôpital Saint-Louis ( Site 0807) — Paris, Île-de-France Region, France
  • Klinikum Stuttgart - Katharinenhospital ( Site 0909) — Stuttgart, Baden-Wurttemberg, Germany
  • Klinikum der Universität München Großhadern ( Site 0910) — Munich, Bavaria, Germany
  • Marienhospital Herne ( Site 0907) — Herne, North Rhine-Westphalia, Germany
  • Universitaetsklinikum Halle ( Site 0902) — Halle, Saxony-Anhalt, Germany
  • Universitaetsklinikum Jena ( Site 0903) — Jena, Thuringia, Germany
  • Henry Dunant Hospital ( Site 1005) — Athens, Attica, Greece
  • Metropolitan General Hospital ( Site 1001) — Athens, Attica, Greece
  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000) — Chaidari/Athens, Attica, Greece
  • European Interbalkan Medical Center-Oncology Department ( Site 1008) — Thessaloniki, Greece
  • Szegedi Tudomanyegyetem ( Site 1113) — Szeged, Csongrád megye, Hungary
  • Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 1116) — Győr, Győr-Moson-Sopron, Hungary
  • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1118) — Eger, Heves County, Hungary
  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaza ( Site 1117) — Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
  • Debreceni Egyetem Klinikai Kozpont ( Site 1112) — Debrecen, Hungary
  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202) — Milan, Lombardy, Italy
  • Istituto Nazionale Tumori Regina Elena ( Site 1201) — Rome, Roma, Italy
  • Azienda USL 8 di Arezzo ( Site 1203) — Arezzo, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1200) — Roma, Italy
  • Rijnstate ( Site 1307) — Arnhem, Gelderland, Netherlands
  • Erasmus MC ( Site 1300) — Rotterdam, South Holland, Netherlands
  • Oncosalud ( Site 0701) — Lima, Lima Province, Peru
  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702) — San Isidro, Lima region, Peru
  • Hospital Militar Central Luis Arias Schereiber ( Site 0700) — Lima, Peru
  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 1402) — Poznan, Greater Poland Voivodeship, Poland
  • Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 1404) — Tarnów, Lesser Poland Voivodeship, Poland
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 1401) — Warszawa, Lesser Poland Voivodeship, Poland
  • Hospital Universitari Parc Tauli ( Site 1505) — Sabadell, Barcelona, Spain
  • Hospital Insular de Gran Canaria ( Site 1502) — Las Palmas de Gran Canaria, Canary Islands, Spain
  • Hospital Clinico San Carlos... ( Site 1500) — Madrid, Spain
  • Hospital Universitario 12 de Octubre ( Site 1507) — Madrid, Spain
  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506) — Madrid, Spain
  • Hospital Universitario Virgen Macarena ( Site 1504) — Seville, Spain
  • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002) — Dusit, Bangkok, Thailand
  • Faculty of Medicine - Khon Kaen University ( Site 3001) — Muang, Changwat Khon Kaen, Thailand
  • Gartnavel General Hospital ( Site 1702) — Glasgow, Glasgow City, United Kingdom
  • St Bartholomew s Hospital ( Site 1700) — London, London, City of, United Kingdom
  • Torbay Hospital ( Site 1701) — Torquay, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record