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NCT06833073PHASE2Recruiting

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

Merck Sharp & Dohme LLC

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

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

Interventions

BIOLOGICAL

Intismeran autogene

BIOLOGICAL

BCG

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Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder NeoplasmsCarcinoma in Situ

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