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Uno studio clinico di V940 e BCG nelle persone con cancro alla vescica (V940-011/Interpath-011)

30 settembre 2026 aggiornato da: Merck Sharp & Dohme LLC

Uno studio randomizzato in aperto di Fase 2 su V940 in combinazione con BCG rispetto alla monoterapia BCG nei partecipanti con carcinoma della vescica invasivo non muscolare ad alto rischio (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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

308

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Biologico: Intismeran autogene

IM injection

Altri nomi:
  • mRNA-4157
  • V940
Biologico: BCG

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

Altri nomi:
  • BCG dal vivo
  • Tice®
  • Theracys®
Comparatore attivo: 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
Biologico: BCG

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

Altri nomi:
  • BCG dal vivo
  • Tice®
  • Theracys®
Sperimentale: Intismeran autogene

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

IM injection

Altri nomi:
  • mRNA-4157
  • V940

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cohort A: Event-free Survival (EFS)
Lasso di tempo: 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): 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.
Up to approximately 5 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cohort A: 12-Month Event-free Survival (EFS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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: 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.
Up to approximately 5 years
Cohort A: Duration of Response (DOR)
Lasso di tempo: 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 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.
Up to approximately 5 years
Cohort A: Time to Cystectomy
Lasso di tempo: Up to approximately 5 years

Time to cystectomy, defined as the time from randomization to the date of radical cystectomy, will be presented for BCG-treated participants.
Up to approximately 5 years
Cohort A: Number of Participants Who Experience an Adverse Event (AE)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merck Sharp & Dohme LLC

Collaboratori

ModernaTX, Inc.

Investigatori

  • Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 marzo 2025

Completamento primario (Stimato)

3 settembre 2031

Completamento dello studio (Stimato)

3 settembre 2031

Date di iscrizione allo studio

Primo inviato

4 febbraio 2025

Primo inviato che soddisfa i criteri di controllo qualità

12 febbraio 2025

Primo Inserito (Effettivo)

18 febbraio 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • V940-011
  • V940-011 (Altro identificatore: MSD)
  • 2024-517335-46-00 (Identificatore di registro: EU CT)
  • U1111-1312-0572 (Identificatore di registro: UTN)
  • INTerpath-011 (Altro identificatore: MSD)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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