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A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
308
Start Date
2025-03-11
Completion Date
2031-09-03
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
Intismeran autogene
IM injection
BCG
Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.
Locations (89)
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 dle 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
CIUSSS de l'Estrie-CHUS ( Site 0204)
Sherbrooke, Quebec, Canada
Oncocentro Valdivia ( Site 0507)
Valdivia, Los Ríos Region, Chile
FALP ( 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, Región de Valparaíso, Chile
Bradford Hill Norte ( Site 0503)
Antofagasta, Chile
Instituto de Cancerología ( 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