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

NCT06833073 | Recruiting Phase 2 FDA Drug

• 4 other identifiers: V940-0112024-517335-46-00U1111-1312-0572INTerpath-011
• Study Type: interventional
• Target: 308
• Locations: 19 countries
• Sites: 89

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cohort A: Event-free Survival (EFS)

  EFS is defined as the time from randomization to any of the following events, as determined by blinded independent central review (BICR) where applicable: High-grade (HG) non-invasive papillary carcinoma (Ta) or carcinoma in situ (CIS) in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of urothelial carcinoma (UC); High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC \[defined as regional lymph node metastasis of UC (stage N1 or greater), or distant lymph node or visceral metastasis of UC (stage M1)\]; Or death due to any cause. The EFS for BCG-treated participants will be presented.

  Up to approximately 5 years

Secondary Outcomes (12)

• Cohort A: 12-Month Event-free Survival (EFS)

  Up to approximately 12 months

• Cohort A: 24-Month Event-free Survival (EFS)

  Up to approximately 24 months

• Cohort A: Recurrence-free Survival (RFS)

  Up to approximately 5 years

• Cohort A: Disease-specific Survival (DSS)

  Up to approximately 5 years

• Cohort A: Overall Survival (OS)

  Up to approximately 5 years

Study Arms (3)

Intismeran autogene + BCG

EXPERIMENTAL

Participants in Cohort A receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. Participants also receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75.

Biological: Intismeran autogene; Biological: BCG

BCG

ACTIVE COMPARATOR

Participants in Cohort A receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75

Biological: BCG

Intismeran autogene

EXPERIMENTAL

Participants in Cohort B receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses.

Biological: Intismeran autogene

Interventions

Intismeran autogene BIOLOGICAL

IM injection

Also known as: mRNA-4157, V940

Intismeran autogene; Intismeran autogene + BCG

BCG BIOLOGICAL

Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.

Also known as: BCG Live, TICE®, TheraCys®

BCG; Intismeran autogene + BCG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• ModernaTX, Inc.: collaborator

Study Sites (89)

Michael G Oefelein Clinical Trials ( Site 0138)

Bakersfield, California, 93301, United States

RECRUITING

Genesis Research, LLC ( Site 0141)

Los Alamitos, California, 90720, United States

ACTIVE NOT RECRUITING

USC Norris Comprehensive Cancer Center ( Site 0123)

Los Angeles, California, 90033, United States

RECRUITING

Genesis Healthcare-Torrance ( Site 0140)

Torrance, California, 90503, United States

RECRUITING

Genesis Research LLC ( Site 0118)

Torrance, California, 90505, United States

RECRUITING

Urology Associates ( Site 0144)

Littleton, Colorado, 80122, United States

RECRUITING

Urological Research Network ( Site 0133)

Hialeah, Florida, 33016, United States

RECRUITING

Associated Urological Specialists - Chicago Ridge ( Site 0139)

Chicago Ridge, Illinois, 60415, United States

RECRUITING

Southern Urology, LLC ( Site 0145)

Lafayette, Louisiana, 70508, United States

RECRUITING

University of Missouri Health Care ( Site 0126)

Columbia, Missouri, 65212, United States

RECRUITING

NHO Revive Research Institute, LLC ( Site 0137)

Lincoln, Nebraska, 68506, United States

RECRUITING

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

New York, New York, 10016, United States

RECRUITING

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

Cincinnati, Ohio, 45212, United States

RECRUITING

OHSU Knight Cancer Institute - South Waterfront ( Site 0110)

Portland, Oregon, 97239, United States

RECRUITING

MidLantic Urology ( Site 0102)

Bala-Cynwyd, Pennsylvania, 19004, United States

RECRUITING

The Conrad Pearson Clinic ( Site 0143)

Germantown, Tennessee, 38138, United States

RECRUITING

Texas Oncology-Austin Central ( Site 0107)

Austin, Texas, 78705, United States

RECRUITING

Urology Austin, PLLC ( Site 0109)

Austin, Texas, 78759, United States

RECRUITING

Urology of Virginia ( Site 0125)

Virginia Beach, Virginia, 23462, United States

RECRUITING

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

Seattle, Washington, 98195, United States

RECRUITING

Hospital Italiano de Buenos Aires ( Site 0307)

CABA, Buenos Aires, C1199ABD, Argentina

RECRUITING

Instituto Alexander Fleming ( Site 0306)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Instituto de Investigaciones Clinicas Mar dle Plata ( Site 0305)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)

Buenos Aires, Buenos Aires F.D., C1419AHN, Argentina

RECRUITING

Fundacion Estudios Clinicos ( Site 0304)

Rosario, Santa Fe Province, S2000DEJ, Argentina

RECRUITING

Sanatorio Parque ( Site 0300)

Rosario, Santa Fe Province, S2000DSV, Argentina

RECRUITING

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

La Rioja, F5300COE, Argentina

RECRUITING

Macquarie University ( Site 1801)

Macquarie University, New South Wales, 2109, Australia

RECRUITING

Fiona Stanley Hospital ( Site 1803)

Perth, Western Australia, 6150, Australia

RECRUITING

Instituto do Câncer e Transplante de Curitiba ( Site 0402)

Curitiba, Paraná, 80510-130, Brazil

RECRUITING

Hospital de Clínicas de Passo Fundo ( Site 0406)

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

RECRUITING

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

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

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

São Jose Do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

The Moncton Hospital-Oncology ( Site 0200)

Moncton, New Brunswick, E1C 6Z8, Canada

RECRUITING

CIUSSS de l'Estrie-CHUS ( Site 0204)

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Oncocentro Valdivia ( Site 0507)

Valdivia, Los Ríos Region, 5112129, Chile

RECRUITING

FALP ( Site 0500)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Pontificia Universidad Catolica de Chile ( Site 0502)

Santiago, Region M. de Santiago, 8330032, Chile

RECRUITING

Bradfordhill ( Site 0501)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

ONCOCENTRO APYS ( Site 0505)

Viña del Mar, Región de Valparaíso, 2520598, Chile

RECRUITING

Bradford Hill Norte ( Site 0503)

Antofagasta, 1240000, Chile

RECRUITING

Instituto de Cancerología ( Site 0600)

Medellín, Antioquia, 050021, Colombia

RECRUITING

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

Bogotá, Bogota D.C., 111321, Colombia

RECRUITING

IMAT S.A.S ( Site 0601)

Montería, Departamento de Córdoba, 230002, Colombia

RECRUITING

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

Pereira, Risaralda Department, 661001, 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, 2730, Denmark

RECRUITING

CHU Dijon Bourgogne ( Site 0802)

Dijon, Cote-d Or, 21079, France

RECRUITING

Bordeaux University Hospital - Pellegrin ( Site 0806)

Bordeaux, Gironde, 33076, France

RECRUITING

CHU de Rouen- urology ( Site 0803)

Rouen, Haute-Normandie, 76031, France

RECRUITING

Hôpital Foch-Urology department ( Site 0801)

Suresnes, Hauts-de-Seine, 92150, France

RECRUITING

Hôpital Saint-Louis ( Site 0807)

Paris, Île-de-France Region, 75010, France

RECRUITING

Klinikum Stuttgart - Katharinenhospital ( Site 0909)

Stuttgart, Baden-Wurttemberg, 70174, Germany

RECRUITING

Klinikum der Universität München Großhadern ( Site 0910)

Munich, Bavaria, 81377, Germany

RECRUITING

Marienhospital Herne ( Site 0907)

Herne, North Rhine-Westphalia, 44625, Germany

RECRUITING

Universitaetsklinikum Halle ( Site 0902)

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Universitaetsklinikum Jena ( Site 0903)

Jena, Thuringia, 07747, Germany

RECRUITING

Henry Dunant Hospital ( Site 1005)

Athens, Attica, 115 26, Greece

RECRUITING

Metropolitan General Hospital ( Site 1001)

Athens, Attica, 155 62, Greece

RECRUITING

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)

Chaidari/Athens, Attica, 124 62, Greece

RECRUITING

European Interbalkan Medical Center-Oncology Department ( Site 1008)

Thessaloniki, 570 01, Greece

RECRUITING

Szegedi Tudomanyegyetem ( Site 1113)

Szeged, Csongrád megye, 6725, Hungary

RECRUITING

Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 1116)

Győr, Győr-Moson-Sopron, 9024, Hungary

RECRUITING

Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1118)

Eger, Heves County, 3300, Hungary

RECRUITING

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaza ( Site 1117)

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont ( Site 1112)

Debrecen, 4032, Hungary

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202)

Milan, Lombardy, 20133, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena ( Site 1201)

Rome, Roma, 00128, Italy

RECRUITING

Azienda USL 8 di Arezzo ( Site 1203)

Arezzo, 52100, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1200)

Roma, 00168, Italy

RECRUITING

Rijnstate ( Site 1307)

Arnhem, Gelderland, 6815 AD, Netherlands

RECRUITING

Erasmus MC ( Site 1300)

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Oncosalud ( Site 0701)

Lima, Lima Province, 15036, Peru

RECRUITING

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702)

San Isidro, Lima region, 15038, Peru

RECRUITING

Hospital Militar Central Luis Arias Schereiber ( Site 0700)

Lima, 15076, Peru

RECRUITING

Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 1402)

Poznan, Greater Poland Voivodeship, 61-731, Poland

RECRUITING

Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 1404)

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 1401)

Warszawa, Lesser Poland Voivodeship, 02-781, Poland

RECRUITING

Hospital Universitari Parc Tauli ( Site 1505)

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital Insular de Gran Canaria ( Site 1502)

Las Palmas de Gran Canaria, Canary Islands, 35016, Spain

RECRUITING

Hospital Clinico San Carlos... ( Site 1500)

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre ( Site 1507)

Madrid, 28041, Spain

RECRUITING

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506)

Madrid, 28223, Spain

RECRUITING

Hospital Universitario Virgen Macarena ( Site 1504)

Seville, 41009, Spain

RECRUITING

Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)

Dusit, Bangkok, 10300, Thailand

RECRUITING

Faculty of Medicine - Khon Kaen University ( Site 3001)

Muang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

Gartnavel General Hospital ( Site 1702)

Glasgow, Glasgow City, G12 0YN, United Kingdom

RECRUITING

St Bartholomew s Hospital ( Site 1700)

London, London, City of, EC1A 7BE, United Kingdom

RECRUITING

Torbay Hospital ( Site 1701)

Torquay, TQ2 7AA, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

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

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants allocated to receive BCG will be randomized 1:1 to the intismeran autogene+BCG arm and the BCG arm (Cohort A). Participants allocated to receive intismeran autogene monotherapy will be allocated to the single intismeran autogene monotherapy arm (Cohort B).

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 18, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): September 3, 2031
• Study Completion (Estimated): September 3, 2031
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (3); FR (5); GB (3); BR (4); DE (5); ES (6); CA (2); NL (2); HU (5); CL (6); GR (4); CO (5); AR (7); IT (4); TH (2); AU (2); DK (1); US (20); PE (3)