En klinisk undersøgelse af V940 og BCG hos mennesker med blærekræft (V940-011/Interpath-011)
En fase 2 åben-label randomiseret undersøgelse af V940 i kombination med BCG versus BCG monoterapi hos deltagere med højrisiko ikke-muskel invasiv blærekræft (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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studiesteder
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La Rioja, Argentina, F5300COE
- Rekruttering
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0301)
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Kontakt:
- Study Coordinator
- Telefonnummer: 543804425438
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1199ABD
- Rekruttering
- Hospital Italiano de Buenos Aires ( Site 0307)
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Kontakt:
- Study Coordinator
- Telefonnummer: 541149590200
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Rekruttering
- Instituto Alexander Fleming ( Site 0306)
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Kontakt:
- Study Coordinator
- Telefonnummer: 5491153288346
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
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- Instituto de Investigaciones Clinicas Mar de Plata ( Site 0305)
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Kontakt:
- Study Coordinator
- Telefonnummer: +542234963224
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentina, C1419AHN
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- Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)
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Kontakt:
- Study Coordinator
- Telefonnummer: +541145740870
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DEJ
- Rekruttering
- Fundacion Estudios Clinicos ( Site 0304)
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Kontakt:
- Study Coordinator
- Telefonnummer: +5403412221472
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Rekruttering
- Sanatorio Parque ( Site 0300)
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Kontakt:
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- Telefonnummer: +543414268409
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New South Wales
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Macquarie University, New South Wales, Australien, 2109
- Rekruttering
- Macquarie University ( Site 1801)
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Kontakt:
- Study Coordinator
- Telefonnummer: +61298122968
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Western Australia
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Perth, Western Australia, Australien, 6150
- Rekruttering
- Fiona Stanley Hospital ( Site 1803)
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Kontakt:
- Study Coordinator
- Telefonnummer: +61861511130
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Paraná
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Curitiba, Paraná, Brasilien, 80510-130
- Rekruttering
- Instituto do Câncer e Transplante de Curitiba ( Site 0402)
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Kontakt:
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- Telefonnummer: +5541992057755
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Rio Grande do Sul
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Passo Fundo, Rio Grande do Sul, Brasilien, 99010-260
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- Hospital de Clínicas de Passo Fundo ( Site 0406)
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Kontakt:
- Study Coordinator
- Telefonnummer: 55 54 981271411
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São Paulo
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Barretos, São Paulo, Brasilien, 14784-400
- Rekruttering
- Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0400)
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Kontakt:
- Study Coordinator
- Telefonnummer: +5517996782301
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São Jose Do Rio Preto, São Paulo, Brasilien, 15090-000
- Rekruttering
- Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0410)
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Kontakt:
- Study Coordinator
- Telefonnummer: 551732015054
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
- Rekruttering
- The Moncton Hospital-Oncology ( Site 0200)
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Kontakt:
- Study Coordinator
- Telefonnummer: 5068574780
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- Rekruttering
- Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0204)
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Kontakt:
- Study Coordinator
- Telefonnummer: 8193461110
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Antofagasta, Chile, 1240000
- Rekruttering
- Bradford Hill Norte ( Site 0503)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56442023631
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Los Ríos Region
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Valdivia, Los Ríos Region, Chile, 5112129
- Rekruttering
- Oncocentro Valdivia ( Site 0507)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56958537020
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 8330032
- Rekruttering
- Pontificia Universidad Catolica de Chile ( Site 0502)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56223543334
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Santiago, Region M. de Santiago, Chile, 8420383
- Rekruttering
- Bradfordhill ( Site 0501)
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Kontakt:
- Study Coordinator
- Telefonnummer: +562 29490970
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Santiago, Region M. de Santiago, Chile, 7500921
- Rekruttering
- Fundación Arturo López Pérez ( Site 0500)
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Kontakt:
- Study Coordinator
- Telefonnummer: 56224218596
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520598
- Rekruttering
- ONCOCENTRO APYS ( Site 0505)
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Kontakt:
- Study Coordinator
- Telefonnummer: +56985719699
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Antioquia
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Medellín, Antioquia, Colombia, 050021
- Aktiv, ikke rekrutterende
- Promotora Médica Las Américas S.A. ( Site 0600)
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 111321
- Rekruttering
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603)
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Kontakt:
- Study Coordinator
- Telefonnummer: +573016254437
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Departamento de Córdoba
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Montería, Departamento de Córdoba, Colombia, 230002
- Rekruttering
- IMAT S.A.S ( Site 0601)
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Kontakt:
- Study Coordinator
- Telefonnummer: +576047862333
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Risaralda Department
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Pereira, Risaralda Department, Colombia, 661001
- Rekruttering
- Oncólogos del Occidente S.A.S. - Sede Pereira ( Site 0604)
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Kontakt:
- Study Coordinator
- Telefonnummer: +573002558656
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia
- Rekruttering
- Clínica Imbanaco S.A.S ( Site 0602)
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Kontakt:
- Study Coordinator
- Telefonnummer: +576023851000
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Capital Region
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Herlev, Capital Region, Danmark, 2730
- Rekruttering
- Herlev and Gentofte Hospital ( Site 3101)
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Kontakt:
- Study Coordinator
- Telefonnummer: +4538683868
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Torquay, Det Forenede Kongerige, TQ2 7AA
- Rekruttering
- Torbay Hospital ( Site 1701)
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Kontakt:
- Study Coordinator
- Telefonnummer: +441803614567
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Glasgow City
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Glasgow, Glasgow City, Det Forenede Kongerige, G12 0YN
- Rekruttering
- Gartnavel General Hospital ( Site 1702)
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Kontakt:
- Study Coordinator
- Telefonnummer: +441413017000
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London, City of
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London, London, City of, Det Forenede Kongerige, EC1A 7BE
- Rekruttering
- St Bartholomew s Hospital ( Site 1700)
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Kontakt:
- Study Coordinator
- Telefonnummer: +4402073777000
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California
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Bakersfield, California, Forenede Stater, 93301
- Rekruttering
- Michael G Oefelein Clinical Trials ( Site 0138)
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Kontakt:
- Study Coordinator
- Telefonnummer: 661-310-1063
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Los Alamitos, California, Forenede Stater, 90720
- Aktiv, ikke rekrutterende
- Genesis Research, LLC ( Site 0141)
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Los Angeles, California, Forenede Stater, 90033
- Rekruttering
- USC Norris Comprehensive Cancer Center ( Site 0123)
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Kontakt:
- Study Coordinator
- Telefonnummer: 800-872-2273
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Torrance, California, Forenede Stater, 90503
- Rekruttering
- Genesis Healthcare-Torrance ( Site 0140)
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Kontakt:
- Study Coordinator
- Telefonnummer: 310-542-0199
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Torrance, California, Forenede Stater, 90505
- Rekruttering
- Genesis Research LLC ( Site 0118)
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Kontakt:
- Study Coordinator
- Telefonnummer: 310-534-8400
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Colorado
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Littleton, Colorado, Forenede Stater, 80122
- Rekruttering
- Urology Associates ( Site 0144)
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Kontakt:
- Study Coordinator
- Telefonnummer: 303-733-8848
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Florida
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Hialeah, Florida, Forenede Stater, 33016
- Rekruttering
- Urological Research Network ( Site 0133)
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Kontakt:
- Study Coordinator
- Telefonnummer: 786-431-2014
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Illinois
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Chicago Ridge, Illinois, Forenede Stater, 60415
- Rekruttering
- Associated Urological Specialists - Chicago Ridge ( Site 0139)
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Kontakt:
- Study Coordinator
- Telefonnummer: 708-566-6983
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Louisiana
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Lafayette, Louisiana, Forenede Stater, 70508
- Rekruttering
- Southern Urology, LLC ( Site 0145)
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Kontakt:
- Study Coordinator
- Telefonnummer: 337-233-6665
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Missouri
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Columbia, Missouri, Forenede Stater, 65212
- Rekruttering
- University of Missouri Health Care ( Site 0126)
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Kontakt:
- Study Coordinator
- Telefonnummer: 573-882-7026
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68506
- Rekruttering
- NHO Revive Research Institute, LLC ( Site 0137)
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Kontakt:
- Study Coordinator
- Telefonnummer: 402-484-4900
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New York
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New York, New York, Forenede Stater, 10016
- Rekruttering
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111)
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Kontakt:
- Study Coordinator
- Telefonnummer: 646-960-1012
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45212
- Rekruttering
- TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0122)
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Kontakt:
- Study Coordinator
- Telefonnummer: 513-841-7700
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- OHSU Knight Cancer Institute - South Waterfront ( Site 0110)
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Kontakt:
- Study Coordinator
- Telefonnummer: 503-494-4779
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forenede Stater, 19004
- Rekruttering
- MidLantic Urology ( Site 0102)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 610-667-0458
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- Rekruttering
- The Conrad Pearson Clinic ( Site 0143)
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Kontakt:
- Study Coordinator
- Telefonnummer: 901-236-0957
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Texas
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Austin, Texas, Forenede Stater, 78759
- Rekruttering
- Urology Austin, PLLC ( Site 0109)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 512-410-3773
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Austin, Texas, Forenede Stater, 78705
- Rekruttering
- Texas Oncology-Austin Central ( Site 0107)
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Kontakt:
- Study Coordinator
- Telefonnummer: 512-421-4235
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Virginia
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Virginia Beach, Virginia, Forenede Stater, 23462
- Rekruttering
- Urology of Virginia ( Site 0125)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 757-457-5100
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Washington
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Seattle, Washington, Forenede Stater, 98195
- Rekruttering
- University of Washington - Fred Hutchinson Cancer Center ( Site 0100)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 206-598-3300
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Cote-d Or
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Dijon, Cote-d Or, Frankrig, 21079
- Rekruttering
- CHU Dijon Bourgogne ( Site 0802)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33380295753
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Gironde
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Bordeaux, Gironde, Frankrig, 33076
- Rekruttering
- Bordeaux University Hospital - Pellegrin ( Site 0806)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33556795547
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Haute-Normandie
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Rouen, Haute-Normandie, Frankrig, 76031
- Rekruttering
- CHU de Rouen- urology ( Site 0803)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33 2 32 88 89 90
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Hauts-de-Seine
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Suresnes, Hauts-de-Seine, Frankrig, 92150
- Rekruttering
- Hôpital Foch-Urology department ( Site 0801)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33146252040
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Île-de-France Region
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Paris, Île-de-France Region, Frankrig, 75010
- Rekruttering
- Hôpital Saint-Louis ( Site 0807)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33142499620
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Thessaloniki, Grækenland, 570 01
- Rekruttering
- European Interbalkan Medical Center-Oncology Department ( Site 1008)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0030 2310400213
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Attica
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Athens, Attica, Grækenland, 155 62
- Rekruttering
- Metropolitan General Hospital ( Site 1001)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0030 2106502831
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Athens, Attica, Grækenland, 115 26
- Rekruttering
- Henry Dunant Hospital ( Site 1005)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0030 2106972246
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Chaidari/Athens, Attica, Grækenland, 124 62
- Rekruttering
- ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0030 2105832549
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Gelderland
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Arnhem, Gelderland, Holland, 6815 AD
- Rekruttering
- Rijnstate ( Site 1307)
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Kontakt:
- Study Coordinator
- Telefonnummer: +31880058124
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South Holland
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Rotterdam, South Holland, Holland, 3015 GD
- Rekruttering
- Erasmus MC ( Site 1300)
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Kontakt:
- Study Coordinator
- Telefonnummer: +31 10 7041566
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Arezzo, Italien, 52100
- Rekruttering
- Azienda USL 8 di Arezzo ( Site 1203)
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Kontakt:
- Study Coordinator
- Telefonnummer: 00390575255434
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Roma, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1200)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0039 06 3015.7080
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Lombardy
-
Milan, Lombardy, Italien, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202)
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Kontakt:
- Study Coordinator
- Telefonnummer: 003902.2390 4450
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Roma
-
Rome, Roma, Italien, 00128
- Rekruttering
- Istituto Nazionale Tumori Regina Elena ( Site 1201)
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Kontakt:
- Study Coordinator
- Telefonnummer: 003906 588961
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Lima, Peru, 15076
- Aktiv, ikke rekrutterende
- Hospital Militar Central Luis Arias Schereiber ( Site 0700)
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Lima Province
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Lima, Lima Province, Peru, 15036
- Rekruttering
- Oncosalud ( Site 0701)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +515137900
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Lima region
-
San Isidro, Lima region, Peru, 15038
- Aktiv, ikke rekrutterende
- IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702)
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-
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Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polen, 61-731
- Rekruttering
- Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 1402)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +48 500 799 053
-
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Lesser Poland Voivodeship
-
Tarnów, Lesser Poland Voivodeship, Polen, 33-100
- Rekruttering
- Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 1404)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +48146315000
-
Warszawa, Lesser Poland Voivodeship, Polen, 02-781
- Afsluttet
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 1401)
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-
-
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Madrid, Spanien, 28040
- Rekruttering
- Hospital Clinico San Carlos... ( Site 1500)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34913303000
-
Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre ( Site 1507)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +34913908121
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Madrid, Spanien, 28223
- Rekruttering
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34914521987
-
Seville, Spanien, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena ( Site 1504)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +3495500800
-
-
Barcelona
-
Sabadell, Barcelona, Spanien, 08208
- Rekruttering
- Hospital Universitari Parc Tauli ( Site 1505)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +34937240084
-
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Canary Islands
-
Las Palmas de Gran Canaria, Canary Islands, Spanien, 35016
- Rekruttering
- Hospital Insular de Gran Canaria ( Site 1502)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +34928441738
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-
-
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Bangkok
-
Dusit, Bangkok, Thailand, 10300
- Rekruttering
- Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +6622443522
-
-
Changwat Khon Kaen
-
Muang, Changwat Khon Kaen, Thailand, 40002
- Rekruttering
- Faculty of Medicine - Khon Kaen University ( Site 3001)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +6643363746
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-
-
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Baden-Wurttemberg
-
Stuttgart, Baden-Wurttemberg, Tyskland, 70174
- Rekruttering
- Klinikum Stuttgart - Katharinenhospital ( Site 0909)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +4971127854720
-
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Bavaria
-
Munich, Bavaria, Tyskland, 81377
- Rekruttering
- Klinikum der Universität München Großhadern ( Site 0910)
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Kontakt:
- Study Coordinator
- Telefonnummer: +4989440072268
-
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North Rhine-Westphalia
-
Herne, North Rhine-Westphalia, Tyskland, 44625
- Rekruttering
- Marienhospital Herne ( Site 0907)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +4923234990
-
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Saxony-Anhalt
-
Halle, Saxony-Anhalt, Tyskland, 06120
- Rekruttering
- Universitaetsklinikum Halle ( Site 0902)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +49 345 557 5810
-
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Thuringia
-
Jena, Thuringia, Tyskland, 07747
- Rekruttering
- Universitaetsklinikum Jena ( Site 0903)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +49 3641 9329901
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-
-
-
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Debrecen, Ungarn, 4032
- Rekruttering
- Debreceni Egyetem Klinikai Kozpont ( Site 1112)
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Kontakt:
- Study Coordinator
- Telefonnummer: +3652255256
-
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Csongrád megye
-
Szeged, Csongrád megye, Ungarn, 6725
- Rekruttering
- Szegedi Tudomanyegyetem ( Site 1113)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +3662545404
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Győr-Moson-Sopron
-
Győr, Győr-Moson-Sopron, Ungarn, 9024
- Rekruttering
- Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 1116)
-
Kontakt:
- Study Coordinator
- Telefonnummer: + 36 96 507 900
-
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Heves County
-
Eger, Heves County, Ungarn, 3300
- Rekruttering
- Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1118)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +3636411444/3802
-
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Szabolcs-Szatmár-Bereg
-
Nyíregyháza, Szabolcs-Szatmár-Bereg, Ungarn, 4400
- Rekruttering
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaza ( Site 1117)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +36 42 599 700
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
IM injection
Andre navne:
Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.
Andre navne:
|
|
Aktiv komparator: 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 |
Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.
Andre navne:
|
|
Eksperimentel: Intismeran autogene
Participants in Cohort B receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. |
IM injection
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cohort A: Event-free Survival (EFS)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cohort A: 12-Month Event-free Survival (EFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Mandlige urogenitale sygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Urologiske neoplasmer
- Karcinom
- Urinblæresygdomme
- Ikke-muskelinvasive blære-neoplasmer
- Karcinom in situ
- Urinblære neoplasmer
- Biologiske produkter
- Komplekse blandinger
- Bakterielle vacciner
- Vacciner
- Tuberkulosevacciner
- BCG-vaccine
Andre undersøgelses-id-numre
- V940-011
- V940-011 (Anden identifikator: MSD)
- 2024-517335-46-00 (Registry Identifier: EU CT)
- U1111-1312-0572 (Registry Identifier: UTN)
- INTerpath-011 (Anden identifikator: MSD)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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