A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Start Date
3/11/2025
Completion Date
9/3/2031
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.
Detailed Description
As of Amendment 03 (effective 01/05/2026), outcome measures associated with the Intismeran autogene Monotherapy Arm (Cohort B) are no longer considered primary or secondary outcome measures.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Intismeran autogene
BCG
Conditions
Locations
Michael G Oefelein Clinical Trials ( Site 0138)
Bakersfield, California 93301
United States
Genesis Research, LLC ( Site 0141)
Los Alamitos, California 90720
United States
USC Norris Comprehensive Cancer Center ( Site 0123)
Los Angeles, California 90033
United States
Genesis Healthcare-Torrance ( Site 0140)
Torrance, California 90503
United States
Genesis Research LLC ( Site 0118)
Torrance, California 90505
United States
Urology Associates ( Site 0144)
Littleton, Colorado 80122
United States
Urological Research Network ( Site 0133)
Hialeah, Florida 33016
United States
Associated Urological Specialists - Chicago Ridge ( Site 0139)
Chicago Ridge, Illinois 60415
United States
Southern Urology, LLC ( Site 0145)
Lafayette, Louisiana 70508
United States
University of Missouri Health Care ( Site 0126)
Columbia, Missouri 65212
United States
NHO Revive Research Institute, LLC ( Site 0137)
Lincoln, Nebraska 68506
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111)
New York, New York 10016
United States
TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0122)
Cincinnati, Ohio 45212
United States
OHSU Knight Cancer Institute - South Waterfront ( Site 0110)
Portland, Oregon 97239
United States
MidLantic Urology ( Site 0102)
Bala-Cynwyd, Pennsylvania 19004
United States
The Conrad Pearson Clinic ( Site 0143)
Germantown, Tennessee 38138
United States
Texas Oncology-Austin Central ( Site 0107)
Austin, Texas 78705
United States
Urology Austin, PLLC ( Site 0109)
Austin, Texas 78759
United States
Urology of Virginia ( Site 0125)
Virginia Beach, Virginia 23462
United States
University of Washington - Fred Hutchinson Cancer Center ( Site 0100)
Seattle, Washington 98195
United States
Hospital Italiano de Buenos Aires ( Site 0307)
CABA, Buenos Aires C1199ABD
Argentina
Instituto Alexander Fleming ( Site 0306)
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
Argentina
Instituto de Investigaciones Clinicas Mar de Plata ( Site 0305)
Mar del Plata, Buenos Aires B7600FZO
Argentina
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)
Buenos Aires, Buenos Aires F.D. C1419AHN
Argentina
Fundacion Estudios Clinicos ( Site 0304)
Rosario, Santa Fe Province S2000DEJ
Argentina
Sanatorio Parque ( Site 0300)
Rosario, Santa Fe Province S2000DSV
Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0301)
La Rioja, F5300COE
Argentina
Macquarie University ( Site 1801)
Macquarie University, New South Wales 2109
Australia
Fiona Stanley Hospital ( Site 1803)
Perth, Western Australia 6150
Australia
Instituto do Câncer e Transplante de Curitiba ( Site 0402)
Curitiba, Paraná 80510-130
Brazil
Hospital de Clínicas de Passo Fundo ( Site 0406)
Passo Fundo, Rio Grande do Sul 99010-260
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0400)
Barretos, São Paulo 14784-400
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0410)
São Jose Do Rio Preto, São Paulo 15090-000
Brazil
The Moncton Hospital-Oncology ( Site 0200)
Moncton, New Brunswick E1C 6Z8
Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0204)
Sherbrooke, Quebec J1H 5N4
Canada
Oncocentro Valdivia ( Site 0507)
Valdivia, Los Ríos Region 5112129
Chile
FALP ( Site 0500)
Santiago, Region M. de Santiago 7500921
Chile
Pontificia Universidad Catolica de Chile ( Site 0502)
Santiago, Region M. de Santiago 8330032
Chile
Bradfordhill ( Site 0501)
Santiago, Region M. de Santiago 8420383
Chile
ONCOCENTRO APYS ( Site 0505)
Viña del Mar, Valparaiso 2520598
Chile
Bradford Hill Norte ( Site 0503)
Antofagasta, 1240000
Chile
Instituto de Cancerología ( Site 0600)
Medellín, Antioquia 050021
Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603)
Bogotá, Bogota D.C. 111321
Colombia
IMAT S.A.S ( Site 0601)
Montería, Departamento de Córdoba 230002
Colombia
Oncólogos del Occidente S.A.S. - Sede Pereira ( Site 0604)
Pereira, Risaralda Department 661001
Colombia
Clínica Imbanaco S.A.S ( Site 0602)
Cali, Valle del Cauca Department
Colombia
Herlev and Gentofte Hospital ( Site 3101)
Herlev, Capital Region 2730
Denmark
CHU Dijon Bourgogne ( Site 0802)
Dijon, Cote-d Or 21079
France
Bordeaux University Hospital - Pellegrin ( Site 0806)
Bordeaux, Gironde 33076
France
CHU de Rouen- urology ( Site 0803)
Rouen, Haute-Normandie 76031
France
Hôpital Foch-Urology department ( Site 0801)
Suresnes, Hauts-de-Seine 92150
France
Hôpital Saint-Louis ( Site 0807)
Paris, Île-de-France Region 75010
France
Klinikum Stuttgart - Katharinenhospital ( Site 0909)
Stuttgart, Baden-Wurttemberg 70174
Germany
Klinikum der Universität München Großhadern ( Site 0910)
Munich, Bavaria 81377
Germany
Marienhospital Herne ( Site 0907)
Herne, North Rhine-Westphalia 44625
Germany
Universitaetsklinikum Halle ( Site 0902)
Halle, Saxony-Anhalt 06120
Germany
Universitaetsklinikum Jena ( Site 0903)
Jena, Thuringia 07747
Germany
Henry Dunant Hospital ( Site 1005)
Athens, Attica 115 26
Greece
Metropolitan General Hospital ( Site 1001)
Athens, Attica 155 62
Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)
Chaidari/Athens, Attica 124 62
Greece
European Interbalkan Medical Center-Oncology Department ( Site 1008)
Thessaloniki, 570 01
Greece
Szegedi Tudomanyegyetem ( Site 1113)
Szeged, Csongrád megye 6725
Hungary
Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 1116)
Győr, Győr-Moson-Sopron 9024
Hungary
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1118)
Eger, Heves County 3300
Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaza ( Site 1117)
Nyíregyháza, Szabolcs-Szatmár-Bereg 4400
Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1112)
Debrecen, 4032
Hungary
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202)
Milan, Lombardy 20133
Italy
Istituto Nazionale Tumori Regina Elena ( Site 1201)
Rome, Roma 00128
Italy
Azienda USL 8 di Arezzo ( Site 1203)
Arezzo, 52100
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1200)
Roma, 00168
Italy
Rijnstate ( Site 1307)
Arnhem, Gelderland 6815 AD
Netherlands
Erasmus MC ( Site 1300)
Rotterdam, South Holland 3015 GD
Netherlands
Oncosalud ( Site 0701)
Lima, Lima Province 15036
Peru
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702)
San Isidro, Lima region 15038
Peru
Hospital Militar Central Luis Arias Schereiber ( Site 0700)
Lima, 15076
Peru
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 1402)
Poznan, Greater Poland Voivodeship 61-731
Poland
Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 1404)
Tarnów, Lesser Poland Voivodeship 33-100
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 1401)
Warszawa, Lesser Poland Voivodeship 02-781
Poland
Hospital Universitari Parc Tauli ( Site 1505)
Sabadell, Barcelona 08208
Spain
Hospital Insular de Gran Canaria ( Site 1502)
Las Palmas de Gran Canaria, Canary Islands 35016
Spain
Hospital Clinico San Carlos... ( Site 1500)
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre ( Site 1507)
Madrid, 28041
Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506)
Madrid, 28223
Spain
Hospital Universitario Virgen Macarena ( Site 1504)
Seville, 41009
Spain
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)
Dusit, Bangkok 10300
Thailand
Faculty of Medicine - Khon Kaen University ( Site 3001)
Muang, Changwat Khon Kaen 40002
Thailand
Gartnavel General Hospital ( Site 1702)
Glasgow, Glasgow City G12 0YN
United Kingdom
St Bartholomew s Hospital ( Site 1700)
London, London, City of EC1A 7BE
United Kingdom
Torbay Hospital ( Site 1701)
Torquay, TQ2 7AA
United Kingdom