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

April 3, 2026 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

308

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • La Rioja, Argentina, F5300COE
        • Recruiting
        • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: 543804425438
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1199ABD
        • Recruiting
        • Hospital Italiano de Buenos Aires ( Site 0307)
        • Contact:
          • Study Coordinator
          • Phone Number: 541149590200
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: 5491153288346
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Recruiting
        • Instituto de Investigaciones Clinicas Mar dle Plata ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: +542234963224
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1419AHN
        • Recruiting
        • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: +541145740870
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DEJ
        • Recruiting
        • Fundacion Estudios Clinicos ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: +5403412221472
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Recruiting
        • Sanatorio Parque ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +543414268409
  • Australia
    • New South Wales
      • Macquarie University, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +61298122968
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: +61861511130
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 80510-130
        • Recruiting
        • Instituto do Câncer e Transplante de Curitiba ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: +5541992057755
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
        • Recruiting
        • Hospital de Clínicas de Passo Fundo ( Site 0406)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 54 981271411
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: +5517996782301
      • São Jose Do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0410)
        • Contact:
          • Study Coordinator
          • Phone Number: 551732015054
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • The Moncton Hospital-Oncology ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: 5068574780
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • CIUSSS de l'Estrie-CHUS ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: 8193461110
  • Chile
      • Antofagasta, Chile, 1240000
        • Recruiting
        • Bradford Hill Norte ( Site 0503)
        • Contact:
          • Study Coordinator
          • Phone Number: +56442023631
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5112129
        • Recruiting
        • Oncocentro Valdivia ( Site 0507)
        • Contact:
          • Study Coordinator
          • Phone Number: +56958537020
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 8330032
        • Recruiting
        • Pontificia Universidad Catolica de Chile ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: +56223543334
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: +562 29490970
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP ( Site 0500)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224218596
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS ( Site 0505)
        • Contact:
          • Study Coordinator
          • Phone Number: +56985719699
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Recruiting
        • Instituto de Cancerología ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: 57 604 3421010x5461
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 111321
        • Recruiting
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: +573016254437
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Recruiting
        • IMAT S.A.S ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +576047862333
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 661001
        • Recruiting
        • Oncólogos del Occidente S.A.S. - Sede Pereira ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: +573002558656
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia
        • Recruiting
        • Clínica Imbanaco S.A.S ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +576023851000
  • Denmark
    • Capital Region
      • Herlev, Capital Region, Denmark, 2730
        • Recruiting
        • Herlev and Gentofte Hospital ( Site 3101)
        • Contact:
          • Study Coordinator
          • Phone Number: +4538683868
  • France
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21079
        • Recruiting
        • CHU Dijon Bourgogne ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: +33380295753
    • Gironde
      • Bordeaux, Gironde, France, 33076
        • Recruiting
        • Bordeaux University Hospital - Pellegrin ( Site 0806)
        • Contact:
          • Study Coordinator
          • Phone Number: +33556795547
    • Haute-Normandie
      • Rouen, Haute-Normandie, France, 76031
        • Recruiting
        • CHU de Rouen- urology ( Site 0803)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 2 32 88 89 90
    • Hauts-de-Seine
      • Suresnes, Hauts-de-Seine, France, 92150
        • Recruiting
        • Hôpital Foch-Urology department ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: +33146252040
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75010
        • Recruiting
        • Hôpital Saint-Louis ( Site 0807)
        • Contact:
          • Study Coordinator
          • Phone Number: +33142499620
  • Germany
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70174
        • Recruiting
        • Klinikum Stuttgart - Katharinenhospital ( Site 0909)
        • Contact:
          • Study Coordinator
          • Phone Number: +4971127854720
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Recruiting
        • Klinikum der Universität München Großhadern ( Site 0910)
        • Contact:
          • Study Coordinator
          • Phone Number: +4989440072268
    • North Rhine-Westphalia
      • Herne, North Rhine-Westphalia, Germany, 44625
        • Recruiting
        • Marienhospital Herne ( Site 0907)
        • Contact:
          • Study Coordinator
          • Phone Number: +4923234990
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Recruiting
        • Universitaetsklinikum Halle ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 345 557 5810
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Recruiting
        • Universitaetsklinikum Jena ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 3641 9329901
  • Greece
      • Thessaloniki, Greece, 570 01
        • Recruiting
        • European Interbalkan Medical Center-Oncology Department ( Site 1008)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2310400213
    • Attica
      • Athens, Attica, Greece, 155 62
        • Recruiting
        • Metropolitan General Hospital ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2106502831
      • Athens, Attica, Greece, 115 26
        • Recruiting
        • Henry Dunant Hospital ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2106972246
      • Chaidari/Athens, Attica, Greece, 124 62
        • Recruiting
        • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2105832549
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont ( Site 1112)
        • Contact:
          • Study Coordinator
          • Phone Number: +3652255256
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6725
        • Recruiting
        • Szegedi Tudomanyegyetem ( Site 1113)
        • Contact:
          • Study Coordinator
          • Phone Number: +3662545404
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Recruiting
        • Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 1116)
        • Contact:
          • Study Coordinator
          • Phone Number: + 36 96 507 900
    • Heves County
      • Eger, Heves County, Hungary, 3300
        • Recruiting
        • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1118)
        • Contact:
          • Study Coordinator
          • Phone Number: +3636411444/3802
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Recruiting
        • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaza ( Site 1117)
        • Contact:
          • Study Coordinator
          • Phone Number: +36 42 599 700
  • Italy
      • Arezzo, Italy, 52100
        • Recruiting
        • Azienda USL 8 di Arezzo ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390575255434
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: 0039 06 3015.7080
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: 003902.2390 4450
    • Roma
      • Rome, Roma, Italy, 00128
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: 003906 588961
  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Recruiting
        • Rijnstate ( Site 1307)
        • Contact:
          • Study Coordinator
          • Phone Number: +31880058124
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmus MC ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 10 7041566
  • Peru
      • Lima, Peru, 15076
        • Recruiting
        • Hospital Militar Central Luis Arias Schereiber ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: +51997468543
    • Lima Province
      • Lima, Lima Province, Peru, 15036
        • Recruiting
        • Oncosalud ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: +515137900
    • Lima region
      • San Isidro, Lima region, Peru, 15038
        • Recruiting
        • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: +512241598
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-731
        • Recruiting
        • Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 500 799 053
    • Lesser Poland Voivodeship
      • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
        • Recruiting
        • Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +48146315000
      • Warszawa, Lesser Poland Voivodeship, Poland, 02-781
        • Completed
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 1401)
  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos... ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913303000
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913908121
      • Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914521987
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: +3495500800
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +34937240084
    • Canary Islands
      • Las Palmas de Gran Canaria, Canary Islands, Spain, 35016
        • Recruiting
        • Hospital Insular de Gran Canaria ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +34928441738
  • Thailand
    • Bangkok
      • Dusit, Bangkok, Thailand, 10300
        • Recruiting
        • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: +6622443522
    • Changwat Khon Kaen
      • Muang, Changwat Khon Kaen, Thailand, 40002
        • Recruiting
        • Faculty of Medicine - Khon Kaen University ( Site 3001)
        • Contact:
          • Study Coordinator
          • Phone Number: +6643363746
  • United Kingdom
      • Torquay, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay Hospital ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +441803614567
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Recruiting
        • Gartnavel General Hospital ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: +441413017000
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew s Hospital ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: +4402073777000
  • United States
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Michael G Oefelein Clinical Trials ( Site 0138)
        • Contact:
          • Study Coordinator
          • Phone Number: 661-310-1063
      • Los Alamitos, California, United States, 90720
        • Active, not recruiting
        • Genesis Research, LLC ( Site 0141)
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center ( Site 0123)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-872-2273
      • Torrance, California, United States, 90503
        • Recruiting
        • Genesis Healthcare-Torrance ( Site 0140)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-542-0199
      • Torrance, California, United States, 90505
        • Recruiting
        • Genesis Research LLC ( Site 0118)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-534-8400
    • Colorado
      • Littleton, Colorado, United States, 80122
        • Recruiting
        • Urology Associates ( Site 0144)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-733-8848
    • Florida
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Urological Research Network ( Site 0133)
        • Contact:
          • Study Coordinator
          • Phone Number: 786-431-2014
    • Illinois
      • Chicago Ridge, Illinois, United States, 60415
        • Recruiting
        • Associated Urological Specialists - Chicago Ridge ( Site 0139)
        • Contact:
          • Study Coordinator
          • Phone Number: 708-566-6983
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • Southern Urology, LLC ( Site 0145)
        • Contact:
          • Study Coordinator
          • Phone Number: 337-233-6665
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri Health Care ( Site 0126)
        • Contact:
          • Study Coordinator
          • Phone Number: 573-882-7026
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • NHO Revive Research Institute, LLC ( Site 0137)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-484-4900
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-960-1012
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0122)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-841-7700
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU Knight Cancer Institute - South Waterfront ( Site 0110)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-494-4779
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • MidLantic Urology ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 610-667-0458
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The Conrad Pearson Clinic ( Site 0143)
        • Contact:
          • Study Coordinator
          • Phone Number: 901-236-0957
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • Urology Austin, PLLC ( Site 0109)
        • Contact:
          • Study Coordinator
          • Phone Number: 512-410-3773
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology-Austin Central ( Site 0107)
        • Contact:
          • Study Coordinator
          • Phone Number: 512-421-4235
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Recruiting
        • Urology of Virginia ( Site 0125)
        • Contact:
          • Study Coordinator
          • Phone Number: 757-457-5100
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington - Fred Hutchinson Cancer Center ( Site 0100)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-598-3300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intismeran autogene + BCG
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: BCG
Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.
Other Names:
  • BCG Live
  • TICE®
  • TheraCys®
Biological: Intismeran autogene
IM injection
Other Names:
  • mRNA-4157
  • V940
Experimental: Intismeran autogene
Participants in Cohort B receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses.
Biological: Intismeran autogene
IM injection
Other Names:
  • mRNA-4157
  • V940
Active Comparator: BCG
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
Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.
Other Names:
  • BCG Live
  • TICE®
  • TheraCys®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort A: Event-free Survival (EFS)
Time Frame: Up to approximately 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort A: 12-Month Event-free Survival (EFS)
Time Frame: Up to approximately 12 months
EFS is defined as the time from randomization to any of the following events, as determined by BICR where applicable: HG Ta or 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 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 at 12 months for BCG-treated participants will be presented.
Up to approximately 12 months
Cohort A: 24-Month Event-free Survival (EFS)
Time Frame: Up to approximately 24 months
EFS is defined as the time from randomization to any of the following events, as determined by BICR where applicable: HG Ta or 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 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 at 24 months for BCG-treated participants will be presented.
Up to approximately 24 months
Cohort A: Recurrence-free Survival (RFS)
Time Frame: Up to approximately 5 years
RFS is defined as the time from randomization to any of the following events, as determined by BICR where applicable: HG Ta or 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 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)]; Death due to any cause; or any other UC recurrence including low-grade (LG) Ta at any timepoint as well as HG Ta or CIS in the bladder before the 24-week assessment. The RFS will be presented.
Up to approximately 5 years
Cohort A: Disease-specific Survival (DSS)
Time Frame: Up to approximately 5 years
DSS is defined as the time from randomization to death due to bladder cancer. The DSS will be presented.
Up to approximately 5 years
Cohort A: Overall Survival (OS)
Time Frame: Up to approximately 5 years
OS is defined as the time from randomization to death due to any cause.
Up to approximately 5 years
Cohort A: 12 Month Overall Survival Rate (OSR)
Time Frame: Up to approximately 12 months
OSR is defined as the percentage of participants who are alive at 12 months. The 12 month OSR for BCG-treated participants will be presented.
Up to approximately 12 months
Cohort A: 24 Month Overall Survival Rate (OSR)
Time Frame: Up to approximately 24 months
OSR is defined as the percentage of participants who are alive at 24 months. The 24 month OSR for BCG-treated participants will be presented.
Up to approximately 24 months
Cohort A: Complete Response Rate (CRR)
Time Frame: Up to approximately 5 years
CRR is defined as the percentage of participants who achieve a Complete Response (CR) defined as the absence of all of the following as determined by BICR using urine cytology, biopsy, and radiology assessments as applicable, and local cystoscopy evaluation: High-risk non-muscle invasive UC (defined as HG Ta, CIS, or any T1 disease of the bladder, urethra, or upper tract [ureters, renal pelvis]); Any T2 or greater in the bladder, including transurethral prostate stromal invasion of UC; Metastatic UC [defined as regional lymph node metastasis of UC (N1 or greater), or distant lymph node or visceral metastasis of UC (M1)]. The CRR for BCG-treated participants will be presented.
Up to approximately 5 years
Cohort A: Duration of Response (DOR)
Time Frame: Up to approximately 5 years
For participants who achieve a Complete Response (CR: the absence of all of the following as determined by BICR using urine cytology, biopsy, and radiology assessments as applicable, and local cystoscopy evaluation: High-risk non-muscle invasive UC (defined as HG Ta, CIS, or any T1 disease of the bladder, urethra, or upper tract [ureters, renal pelvis]); Any T2 or greater in the bladder, including transurethral prostate stromal invasion of UC; Metastatic UC [defined as regional lymph node metastasis of UC (N1 or greater), or distant lymph node or visceral metastasis of UC (M1)]), DOR is defined as the time from first documented CR to the first occurrence of any of the following: High-risk non-muscle invasive UC; muscle-invasive bladder cancer (MIBC) or locally-advanced or metastatic UC; Or death due to any cause. DOR as assessed by BICR will be presented.
Up to approximately 5 years
Cohort A: Time to Cystectomy
Time Frame: Up to approximately 5 years
Time to cystectomy, defined as the time from randomization to the date of cystectomy, will be presented for BCG-treated participants.
Up to approximately 5 years
Cohort A: Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 21 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE in the study will be presented.
Up to approximately 21 months
Cohort A: Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 18 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue the study intervention due to an AE in the study will be presented.
Up to approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

ModernaTX, Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2025

Primary Completion (Estimated)

September 3, 2031

Study Completion (Estimated)

September 3, 2031

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V940-011 (Other Identifier: MSD)
  • 2024-517335-46-00 (Registry Identifier: EU CT)
  • U1111-1312-0572 (Registry Identifier: UTN)
  • INTerpath-011 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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