AzTrials
AzTrials

Urinary Bladder NeoplasmsPhase 2NCT06833073

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

A Phase 2 study testing Intismeran autogene and BCG in people with Urinary Bladder Neoplasms and Non-Muscle Invasive Bladder Neoplasms, run by Merck Sharp & Dohme LLC at 89 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intismeran autogene and BCG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
89 sitesin 19 countries
Study dates
11 Mar 2025to 3 Sep 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

89 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

89 sites in 19 countries

United States20 sites, 19 recruiting

  • Texas Oncology-Austin Central ( Site 0107)

    Austin, Texas, 78705

    Study Coordinator, 512-421-4235

    Recruiting

  • Urology Austin, PLLC ( Site 0109)

    Austin, Texas, 78759

    Study Coordinator, 512-410-3773

    Recruiting

  • Michael G Oefelein Clinical Trials ( Site 0138)

    Bakersfield, California, 93301

    Study Coordinator, 661-310-1063

    Recruiting

  • MidLantic Urology ( Site 0102)

    Bala-Cynwyd, Pennsylvania, 19004

    Study Coordinator, 610-667-0458

    Recruiting

  • Associated Urological Specialists - Chicago Ridge ( Site 0139)

    Chicago Ridge, Illinois, 60415

    Study Coordinator, 708-566-6983

    Recruiting

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

    Cincinnati, Ohio, 45212

    Study Coordinator, 513-841-7700

    Recruiting

  • University of Missouri Health Care ( Site 0126)

    Columbia, Missouri, 65212

    Study Coordinator, 573-882-7026

    Recruiting

  • The Conrad Pearson Clinic ( Site 0143)

    Germantown, Tennessee, 38138

    Study Coordinator, 901-236-0957

    Recruiting

  • Urological Research Network ( Site 0133)

    Hialeah, Florida, 33016

    Study Coordinator, 786-431-2014

    Recruiting

  • Southern Urology, LLC ( Site 0145)

    Lafayette, Louisiana, 70508

    Study Coordinator, 337-233-6665

    Recruiting

  • NHO Revive Research Institute, LLC ( Site 0137)

    Lincoln, Nebraska, 68506

    Study Coordinator, 402-484-4900

    Recruiting

  • Urology Associates ( Site 0144)

    Littleton, Colorado, 80122

    Study Coordinator, 303-733-8848

    Recruiting

  • Genesis Research, LLC ( Site 0141)

    Los Alamitos, California, 90720

    Active, not recruiting

  • USC Norris Comprehensive Cancer Center ( Site 0123)

    Los Angeles, California, 90033

    Study Coordinator, 800-872-2273

    Recruiting

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

    New York, New York, 10016

    Study Coordinator, 646-960-1012

    Recruiting

  • OHSU Knight Cancer Institute - South Waterfront ( Site 0110)

    Portland, Oregon, 97239

    Study Coordinator, 503-494-4779

    Recruiting

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

    Seattle, Washington, 98195

    Study Coordinator, 206-598-3300

    Recruiting

  • Genesis Healthcare-Torrance ( Site 0140)

    Torrance, California, 90503

    Study Coordinator, 310-542-0199

    Recruiting

  • Genesis Research LLC ( Site 0118)

    Torrance, California, 90505

    Study Coordinator, 310-534-8400

    Recruiting

  • Urology of Virginia ( Site 0125)

    Virginia Beach, Virginia, 23462

    Study Coordinator, 757-457-5100

    Recruiting

Other trials in United States

Argentina7 sites, 7 recruiting

  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)

    Buenos Aires, Buenos Aires F.D., C1419AHN

    Study Coordinator, +541145740870

    Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0307)

    CABA, Buenos Aires, C1199ABD

    Study Coordinator, 541149590200

    Recruiting

  • Instituto Alexander Fleming ( Site 0306)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

    Study Coordinator, 5491153288346

    Recruiting

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

    La Rioja, F5300COE

    Study Coordinator, 543804425438

    Recruiting

  • Instituto de Investigaciones Clinicas Mar de Plata ( Site 0305)

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, +542234963224

    Recruiting

  • Fundacion Estudios Clinicos ( Site 0304)

    Rosario, Santa Fe Province, S2000DEJ

    Study Coordinator, +5403412221472

    Recruiting

  • Sanatorio Parque ( Site 0300)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, +543414268409

    Recruiting

Other trials in Argentina

Chile6 sites, 6 recruiting

  • Bradford Hill Norte ( Site 0503)

    Antofagasta, 1240000

    Study Coordinator, +56442023631

    Recruiting

  • Fundación Arturo López Pérez ( Site 0500)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224218596

    Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 0502)

    Santiago, Region M. de Santiago, 8330032

    Study Coordinator, +56223543334

    Recruiting

  • Bradfordhill ( Site 0501)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +562 29490970

    Recruiting

  • Oncocentro Valdivia ( Site 0507)

    Valdivia, Los Ríos Region, 5112129

    Study Coordinator, +56958537020

    Recruiting

  • ONCOCENTRO APYS ( Site 0505)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, +56985719699

    Recruiting

Other trials in Chile

Spain6 sites, 6 recruiting

  • Hospital Insular de Gran Canaria ( Site 1502)

    Las Palmas de Gran Canaria, Canary Islands, 35016

    Study Coordinator, +34928441738

    Recruiting

  • Hospital Clinico San Carlos... ( Site 1500)

    Madrid, 28040

    Study Coordinator, +34913303000

    Recruiting

  • Hospital Universitario 12 de Octubre ( Site 1507)

    Madrid, 28041

    Study Coordinator, +34913908121

    Recruiting

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506)

    Madrid, 28223

    Study Coordinator, +34914521987

    Recruiting

  • Hospital Universitari Parc Tauli ( Site 1505)

    Sabadell, Barcelona, 08208

    Study Coordinator, +34937240084

    Recruiting

  • Hospital Universitario Virgen Macarena ( Site 1504)

    Seville, 41009

    Study Coordinator, +3495500800

    Recruiting

Other trials in Spain

Colombia5 sites, 4 recruiting

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

    Bogotá, Bogota D.C., 111321

    Study Coordinator, +573016254437

    Recruiting

  • Clínica Imbanaco S.A.S ( Site 0602)

    Cali, Valle del Cauca Department

    Study Coordinator, +576023851000

    Recruiting

  • Promotora Médica Las Américas S.A. ( Site 0600)

    Medellín, Antioquia, 050021

    Active, not recruiting

  • IMAT S.A.S ( Site 0601)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, +576047862333

    Recruiting

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

    Pereira, Risaralda Department, 661001

    Study Coordinator, +573002558656

    Recruiting

Other trials in Colombia

France5 sites, 5 recruiting

  • Bordeaux University Hospital - Pellegrin ( Site 0806)

    Bordeaux, Gironde, 33076

    Study Coordinator, +33556795547

    Recruiting

  • CHU Dijon Bourgogne ( Site 0802)

    Dijon, Cote-d Or, 21079

    Study Coordinator, +33380295753

    Recruiting

  • Hôpital Saint-Louis ( Site 0807)

    Paris, Île-de-France Region, 75010

    Study Coordinator, +33142499620

    Recruiting

  • CHU de Rouen- urology ( Site 0803)

    Rouen, Haute-Normandie, 76031

    Study Coordinator, +33 2 32 88 89 90

    Recruiting

  • Hôpital Foch-Urology department ( Site 0801)

    Suresnes, Hauts-de-Seine, 92150

    Study Coordinator, +33146252040

    Recruiting

Other trials in France

Germany5 sites, 5 recruiting

  • Universitaetsklinikum Halle ( Site 0902)

    Halle, Saxony-Anhalt, 06120

    Study Coordinator, +49 345 557 5810

    Recruiting

  • Marienhospital Herne ( Site 0907)

    Herne, North Rhine-Westphalia, 44625

    Study Coordinator, +4923234990

    Recruiting

  • Universitaetsklinikum Jena ( Site 0903)

    Jena, Thuringia, 07747

    Study Coordinator, +49 3641 9329901

    Recruiting

  • Klinikum der Universität München Großhadern ( Site 0910)

    Munich, Bavaria, 81377

    Study Coordinator, +4989440072268

    Recruiting

  • Klinikum Stuttgart - Katharinenhospital ( Site 0909)

    Stuttgart, Baden-Wurttemberg, 70174

    Study Coordinator, +4971127854720

    Recruiting

Other trials in Germany

Hungary5 sites, 5 recruiting

  • Debreceni Egyetem Klinikai Kozpont ( Site 1112)

    Debrecen, 4032

    Study Coordinator, +3652255256

    Recruiting

  • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1118)

    Eger, Heves County, 3300

    Study Coordinator, +3636411444/3802

    Recruiting

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

    Győr, Győr-Moson-Sopron, 9024

    Study Coordinator, + 36 96 507 900

    Recruiting

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

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

    Study Coordinator, +36 42 599 700

    Recruiting

  • Szegedi Tudomanyegyetem ( Site 1113)

    Szeged, Csongrád megye, 6725

    Study Coordinator, +3662545404

    Recruiting

Other trials in Hungary

Brazil4 sites, 4 recruiting

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

    Barretos, São Paulo, 14784-400

    Study Coordinator, +5517996782301

    Recruiting

  • Instituto do Câncer e Transplante de Curitiba ( Site 0402)

    Curitiba, Paraná, 80510-130

    Study Coordinator, +5541992057755

    Recruiting

  • Hospital de Clínicas de Passo Fundo ( Site 0406)

    Passo Fundo, Rio Grande do Sul, 99010-260

    Study Coordinator, 55 54 981271411

    Recruiting

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

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

    Study Coordinator, 551732015054

    Recruiting

Other trials in Brazil

Greece4 sites, 4 recruiting

  • Henry Dunant Hospital ( Site 1005)

    Athens, Attica, 115 26

    Study Coordinator, 0030 2106972246

    Recruiting

  • Metropolitan General Hospital ( Site 1001)

    Athens, Attica, 155 62

    Study Coordinator, 0030 2106502831

    Recruiting

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)

    Chaidari/Athens, Attica, 124 62

    Study Coordinator, 0030 2105832549

    Recruiting

  • European Interbalkan Medical Center-Oncology Department ( Site 1008)

    Thessaloniki, 570 01

    Study Coordinator, 0030 2310400213

    Recruiting

Other trials in Greece

Italy4 sites, 4 recruiting

  • Azienda USL 8 di Arezzo ( Site 1203)

    Arezzo, 52100

    Study Coordinator, 00390575255434

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202)

    Milan, Lombardy, 20133

    Study Coordinator, 003902.2390 4450

    Recruiting

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

    Roma, 00168

    Study Coordinator, 0039 06 3015.7080

    Recruiting

  • Istituto Nazionale Tumori Regina Elena ( Site 1201)

    Rome, Roma, 00128

    Study Coordinator, 003906 588961

    Recruiting

Other trials in Italy

Peru3 sites, 1 recruiting

  • Oncosalud ( Site 0701)

    Lima, Lima Province, 15036

    Study Coordinator, +515137900

    Recruiting

  • Hospital Militar Central Luis Arias Schereiber ( Site 0700)

    Lima, 15076

    Active, not recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702)

    San Isidro, Lima region, 15038

    Active, not recruiting

Other trials in Peru

Poland3 sites, 2 recruiting

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

    Poznan, Greater Poland Voivodeship, 61-731

    Study Coordinator, +48 500 799 053

    Recruiting

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

    Tarnów, Lesser Poland Voivodeship, 33-100

    Study Coordinator, +48146315000

    Recruiting

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

    Warszawa, Lesser Poland Voivodeship, 02-781

    Completed

Other trials in Poland

United Kingdom3 sites, 3 recruiting

  • Gartnavel General Hospital ( Site 1702)

    Glasgow, Glasgow City, G12 0YN

    Study Coordinator, +441413017000

    Recruiting

  • St Bartholomew s Hospital ( Site 1700)

    London, London, City of, EC1A 7BE

    Study Coordinator, +4402073777000

    Recruiting

  • Torbay Hospital ( Site 1701)

    Torquay, TQ2 7AA

    Study Coordinator, +441803614567

    Recruiting

Other trials in United Kingdom

Australia2 sites, 2 recruiting

  • Macquarie University ( Site 1801)

    Macquarie University, New South Wales, 2109

    Study Coordinator, +61298122968

    Recruiting

  • Fiona Stanley Hospital ( Site 1803)

    Perth, Western Australia, 6150

    Study Coordinator, +61861511130

    Recruiting

Other trials in Australia

Canada2 sites, 2 recruiting

  • The Moncton Hospital-Oncology ( Site 0200)

    Moncton, New Brunswick, E1C 6Z8

    Study Coordinator, 5068574780

    Recruiting

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0204)

    Sherbrooke, Quebec, J1H 5N4

    Study Coordinator, 8193461110

    Recruiting

Other trials in Canada

Netherlands2 sites, 2 recruiting

  • Rijnstate ( Site 1307)

    Arnhem, Gelderland, 6815 AD

    Study Coordinator, +31880058124

    Recruiting

  • Erasmus MC ( Site 1300)

    Rotterdam, South Holland, 3015 GD

    Study Coordinator, +31 10 7041566

    Recruiting

Other trials in Netherlands

Thailand2 sites, 2 recruiting

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

    Dusit, Bangkok, 10300

    Study Coordinator, +6622443522

    Recruiting

  • Faculty of Medicine - Khon Kaen University ( Site 3001)

    Muang, Changwat Khon Kaen, 40002

    Study Coordinator, +6643363746

    Recruiting

Other trials in Thailand

Denmark1 site, 1 recruiting

  • Herlev and Gentofte Hospital ( Site 3101)

    Herlev, Capital Region, 2730

    Study Coordinator, +4538683868

    Recruiting

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
Intismeran autogene, BCG
Medical subject headings
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intismeran autogeneBiological

    Also called mRNA-4157, V940

    IM injection

  • BCGBiological

    Also called BCG Live, TICE®, TheraCys®

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

Study groups in NCT06833073
Study groupRoleWhat they receive
Intismeran autogene + BCGExperimentalParticipants 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.
Receives: Biological: Intismeran autogene; Biological: BCG
BCGActive comparatorParticipants 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
Receives: Biological: BCG
Intismeran autogeneExperimentalParticipants in Cohort B receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses.
Receives: Biological: Intismeran autogene

What is being measured

The primary outcome is the main question the study is designed to answer.

  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): 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 metastasis of UC including non-regional lymph nodes (stage M1)]; Or death due to any cause. The EFS for BCG-treated participants will be presented.

    Measured: Up to approximately 5 years

Secondary outcomes (12)

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

    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.

    Measured: Up to approximately 12 months

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

    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.

    Measured: Up to approximately 24 months

  3. Cohort A: Recurrence-free Survival (RFS)

    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.

    Measured: Up to approximately 5 years

  4. Cohort A: Disease-specific Survival (DSS)

    DSS is defined as the time from randomization to death due to bladder cancer. The DSS will be presented.

    Measured: Up to approximately 5 years

  5. Cohort A: Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 5 years

  6. Cohort A: 12 Month Overall Survival Rate (OSR)

    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.

    Measured: Up to approximately 12 months

  7. Cohort A: 24 Month Overall Survival Rate (OSR)

    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.

    Measured: Up to approximately 24 months

  8. Cohort A: Complete Response Rate (CRR)

    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: 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 metastasis of UC including non-regional lymph nodes (M1)]. The CRR for BCG-treated participants will be presented.

    Measured: Up to approximately 5 years

  9. Cohort A: Duration of Response (DOR)

    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 UC in the bladder, urethra; Any T2 or greater UC in the bladder, including transurethral prostate stromal invasion of UC; Extravesical UC as defined in CR; 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.

    Measured: Up to approximately 5 years

  10. Cohort A: Time to Cystectomy

    Time to cystectomy, defined as the time from randomization to the date of radical cystectomy, will be presented for BCG-treated participants.

    Measured: Up to approximately 5 years

  11. Cohort A: Number of Participants Who Experience an Adverse Event (AE)

    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.

    Measured: Up to approximately 21 months

  12. Cohort A: Number of Participants Who Discontinue Study Intervention Due to an AE

    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.

    Measured: Up to approximately 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start11 Mar 2025
  3. Primary completion3 Sep 2031 (estimated)
  4. Study completion3 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
308 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06833073
Sponsor's protocol ID
V940-011
Other IDs
2024-517335-46-00, U1111-1312-0572, INTerpath-011, V940-011
Status last verified
Sep 2026
First submitted
4 Feb 2025
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intismeran autogene and BCG in people with Urinary Bladder Neoplasms and Non-Muscle Invasive Bladder Neoplasms, run by Merck Sharp & Dohme LLC at 89 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Argentina, Chile, Spain, Colombia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort A: Event-free Survival (EFS) (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06833073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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