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

NCT ID: NCT06833073

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-11

Study Completion Date

2031-09-03

Brief Summary

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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 goals of this study are to learn:

* If people who receive intismeran autogene with BCG live longer without the cancer growing, spreading, or coming back, or dying from any cause, compared to people who receive BCG alone
* If more people who receive intismeran autogene with BCG have their cancer go away (complete response), compared to people who receive BCG alone
* How many people who receive intismeran autogene without BCG have their cancer go away

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants allocated to receive BCG will be randomized 1:1 to the intismeran autogene+BCG arm and the BCG arm.

Participants allocated to receive intismeran autogene monotherapy will be allocated to the single intismeran autogene monotherapy arm.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intismeran autogene + BCG

Participants 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.

Group Type EXPERIMENTAL

Intismeran autogene

Intervention Type BIOLOGICAL

IM injection

BCG

Intervention Type BIOLOGICAL

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

BCG

Participants 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.

Group Type ACTIVE_COMPARATOR

BCG

Intervention Type BIOLOGICAL

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

Intismeran autogene

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

Group Type EXPERIMENTAL

Intismeran autogene

Intervention Type BIOLOGICAL

IM injection

Interventions

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Intismeran autogene

IM injection

Intervention Type BIOLOGICAL

BCG

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

Intervention Type BIOLOGICAL

Other Intervention Names

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mRNA-4157 V940 BCG Live TICE® TheraCys®

Eligibility Criteria

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Inclusion Criteria

\- Is an individual whose most recent TURBT was performed within 12 weeks before randomization/allocation and showed BICR-confirmed high-risk NMIBC histology

BCG Arms:

* 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

Intismeran autogene Monotherapy Arm:

* 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

* 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)

BCG Arms:

* Has current active tuberculosis
* Has a known history of HIV infection

Intismeran autogene Monotherapy Arm:

\- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ModernaTX, Inc.

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Michael G Oefelein Clinical Trials ( Site 0138)

Bakersfield, California, United States

Site Status RECRUITING

Genesis Research, LLC ( Site 0141)

Los Alamitos, California, United States

Site Status ACTIVE_NOT_RECRUITING

USC Norris Comprehensive Cancer Center ( Site 0123)

Los Angeles, California, United States

Site Status RECRUITING

Genesis Healthcare-Torrance ( Site 0140)

Torrance, California, United States

Site Status RECRUITING

Genesis Research LLC ( Site 0118)

Torrance, California, United States

Site Status RECRUITING

Urology Associates ( Site 0144)

Littleton, Colorado, United States

Site Status RECRUITING

Urological Research Network ( Site 0133)

Hialeah, Florida, United States

Site Status RECRUITING

Associated Urological Specialists - Chicago Ridge ( Site 0139)

Chicago Ridge, Illinois, United States

Site Status RECRUITING

Southern Urology, LLC ( Site 0145)

Lafayette, Louisiana, United States

Site Status RECRUITING

University of Missouri Health Care ( Site 0126)

Columbia, Missouri, United States

Site Status RECRUITING

NHO Revive Research Institute, LLC ( Site 0137)

Lincoln, Nebraska, United States

Site Status RECRUITING

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

New York, New York, United States

Site Status RECRUITING

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

Cincinnati, Ohio, United States

Site Status RECRUITING

OHSU Knight Cancer Institute - South Waterfront ( Site 0110)

Portland, Oregon, United States

Site Status RECRUITING

MidLantic Urology ( Site 0102)

Bala-Cynwyd, Pennsylvania, United States

Site Status RECRUITING

The Conrad Pearson Clinic ( Site 0143)

Germantown, Tennessee, United States

Site Status RECRUITING

Texas Oncology-Austin Central ( Site 0107)

Austin, Texas, United States

Site Status RECRUITING

Urology Austin, PLLC ( Site 0109)

Austin, Texas, United States

Site Status RECRUITING

Urology of Virginia ( Site 0125)

Virginia Beach, Virginia, United States

Site Status RECRUITING

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

Seattle, Washington, United States

Site Status RECRUITING

Hospital Italiano de Buenos Aires ( Site 0307)

CABA, Buenos Aires, Argentina

Site Status RECRUITING

Instituto Alexander Fleming ( Site 0306)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status RECRUITING

Instituto de Investigaciones Clinicas Mar dle Plata ( Site 0305)

Mar del Plata, Buenos Aires, Argentina

Site Status RECRUITING

Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Sanatorio Parque ( Site 0300)

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Fundacion Estudios Clinicos ( Site 0304)

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

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

La Rioja, , Argentina

Site Status RECRUITING

Macquarie University ( Site 1801)

Macquarie University, New South Wales, Australia

Site Status RECRUITING

Fiona Stanley Hospital ( Site 1803)

Perth, Western Australia, Australia

Site Status RECRUITING

Instituto do Câncer e Transplante de Curitiba ( Site 0402)

Curitiba, Paraná, Brazil

Site Status RECRUITING

Hospital de Clínicas de Passo Fundo ( Site 0406)

Passo Fundo, Rio Grande do Sul, Brazil

Site Status RECRUITING

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

Barretos, São Paulo, Brazil

Site Status RECRUITING

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

São Jose Do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

The Moncton Hospital-Oncology ( Site 0200)

Moncton, New Brunswick, Canada

Site Status RECRUITING

CIUSSS de l'Estrie-CHUS ( Site 0204)

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Oncocentro Valdivia ( Site 0507)

Valdivia, Los Ríos Region, Chile

Site Status RECRUITING

FALP ( Site 0500)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Pontificia Universidad Catolica de Chile ( Site 0502)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Bradfordhill ( Site 0501)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

ONCOCENTRO APYS ( Site 0505)

Valparaíso, Region M. de Santiago, Chile

Site Status RECRUITING

Bradford Hill Norte ( Site 0503)

Antofagasta, , Chile

Site Status RECRUITING

Instituto de Cancerología ( Site 0600)

Medellín, Antioquia, Colombia

Site Status RECRUITING

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

Bogotá, Bogota D.C., Colombia

Site Status RECRUITING

IMAT S.A.S ( Site 0601)

Montería, Departamento de Córdoba, Colombia

Site Status RECRUITING

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

Pereira, Risaralda Department, Colombia

Site Status RECRUITING

Clínica Imbanaco S.A.S ( Site 0602)

Cali, Valle del Cauca Department, Colombia

Site Status RECRUITING

Herlev and Gentofte Hospital ( Site 3101)

Herlev, Capital Region, Denmark

Site Status RECRUITING

CHU Dijon Bourgogne ( Site 0802)

Dijon, Cote-d Or, France

Site Status RECRUITING

Bordeaux University Hospital - Pellegrin ( Site 0806)

Bordeaux, Gironde, France

Site Status RECRUITING

CHU de Rouen- urology ( Site 0803)

Rouen, Haute-Normandie, France

Site Status RECRUITING

Hôpital Foch-Urology department ( Site 0801)

Suresnes, Hauts-de-Seine, France

Site Status RECRUITING

Hôpital Saint-Louis ( Site 0807)

Paris, Île-de-France Region, France

Site Status RECRUITING

Klinikum Stuttgart - Katharinenhospital ( Site 0909)

Stuttgart, Baden-Wurttemberg, Germany

Site Status RECRUITING

Klinikum der Universität München Großhadern ( Site 0910)

Munich, Bavaria, Germany

Site Status RECRUITING

Marienhospital Herne ( Site 0907)

Herne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitaetsklinikum Halle ( Site 0902)

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Universitaetsklinikum Jena ( Site 0903)

Jena, Thuringia, Germany

Site Status RECRUITING

Henry Dunant Hospital ( Site 1005)

Athens, Attica, Greece

Site Status RECRUITING

Metropolitan General Hospital ( Site 1001)

Athens, Attica, Greece

Site Status RECRUITING

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)

Chaidari/Athens, Attica, Greece

Site Status RECRUITING

European Interbalkan Medical Center-Oncology Department ( Site 1008)

Thessaloniki, , Greece

Site Status RECRUITING

Szegedi Tudomanyegyetem ( Site 1113)

Szeged, Csongrád megye, Hungary

Site Status RECRUITING

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

Győr, Győr-Moson-Sopron, Hungary

Site Status RECRUITING

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

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Site Status RECRUITING

Debreceni Egyetem Klinikai Kozpont ( Site 1112)

Debrecen, , Hungary

Site Status RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202)

Milan, Lombardy, Italy

Site Status RECRUITING

Istituto Nazionale Tumori Regina Elena ( Site 1201)

Rome, Roma, Italy

Site Status RECRUITING

Azienda USL 8 di Arezzo ( Site 1203)

Arezzo, , Italy

Site Status RECRUITING

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

Roma, , Italy

Site Status RECRUITING

Rijnstate ( Site 1307)

Arnhem, Gelderland, Netherlands

Site Status RECRUITING

Erasmus MC ( Site 1300)

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Oncosalud ( Site 0701)

Lima, Lima Province, Peru

Site Status RECRUITING

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702)

San Isidro, Lima region, Peru

Site Status RECRUITING

Hospital Militar Central Luis Arias Schereiber ( Site 0700)

Lima, , Peru

Site Status RECRUITING

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

Poznan, Greater Poland Voivodeship, Poland

Site Status RECRUITING

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

Tarnów, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

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

Warszawa, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

Hospital Universitari Parc Tauli ( Site 1505)

Sabadell, Barcelona, Spain

Site Status RECRUITING

Hospital Insular de Gran Canaria ( Site 1502)

Las Palmas de Gran Canaria, Canary Islands, Spain

Site Status RECRUITING

Hospital Clinico San Carlos... ( Site 1500)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre ( Site 1507)

Madrid, , Spain

Site Status RECRUITING

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena ( Site 1504)

Seville, , Spain

Site Status RECRUITING

St Bartholomew s Hospital ( Site 1700)

London, London, City of, United Kingdom

Site Status RECRUITING

Torbay Hospital ( Site 1701)

Torquay, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Brazil Canada Chile Colombia Denmark France Germany Greece Hungary Italy Netherlands Peru Poland Spain United Kingdom

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

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Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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2024-517335-46-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1312-0572

Identifier Type: REGISTRY

Identifier Source: secondary_id

INTerpath-011

Identifier Type: OTHER

Identifier Source: secondary_id

V940-011

Identifier Type: OTHER

Identifier Source: secondary_id

V940-011

Identifier Type: -

Identifier Source: org_study_id