En undersøgelse af TAR-200 versus intravesikal kemoterapi hos deltagere med tilbagevendende højrisiko ikke-muskelinvasiv blærekræft (HR-NMIBC) efter Bacillus Calmette-Guérin (BCG) (SunRISe-5)
Et fase 3, randomiseret, åbent, multicenter-studie, der evaluerer effektiviteten og sikkerheden af TAR-200 versus efterforskerens valg af intravesikal kemoterapi hos deltagere, der modtog Bacillus Calmette-Guérin (BCG) og gentog sig med højrisiko ikke-muskel- invasiv blærekræft (HR-NMIBC) og som ikke er berettiget til eller valgt ikke at gennemgå radikal cystektomi
The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Buenos Aires, Argentina, C1406
- Clinica Santa Isabel
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CABA, Argentina, C1425
- Investigaciones Clinico Moleculares (ICM)
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Córdoba, Argentina, 5000
- Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
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Córdoba, Argentina, X5000KPH
- Centro Urologico Profesor Bengio
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Mar del Plata, Argentina, B7602
- Hospital Privado de la Comunidad
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Bruges, Belgien, 8000
- AZ Sint-Jan
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Brussels, Belgien, 1200
- Cliniques Universitaires Saint Luc
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Genk, Belgien, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Belgien, 9000
- Algemeen ziekenhuis Maria Middelares
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Roeselare, Belgien, 8800
- Algemeen Ziekenhuis Delta
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Barretos, Brasilien, 14784-400
- Fundacao Pio XII
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Bauru, Brasilien, 17030-495
- NAIC Nair Antunes Instituto do Cancer
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Campinas, Brasilien, 13083-872
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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Curitiba, Brasilien, 81520-060
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Porto Alegre, Brasilien, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Salvador, Brasilien, 41810-011
- Hospital da Bahia
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São Paulo, Brasilien, 01308 901
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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São Paulo, Brasilien, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasilien, 01323 900
- Real e Benemérita Associação Portuguesa de Beneficência
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London, Det Forenede Kongerige, EC1A 7BE
- St Bartholomews Hospital
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Salford, Det Forenede Kongerige, M6 8HD
- Salford Royal Hospital
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Southampton, Det Forenede Kongerige, SO16 6YD
- Southampton University Hospital
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Stevenage, Det Forenede Kongerige, SG1 4AB
- Lister Hospital
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72211
- Arkansas Urology
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California
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Los Alamitos, California, Forenede Stater, 90720
- Genesis Research LLC 1
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Los Angeles, California, Forenede Stater, 90033
- USC Norris Comprehensive Cancer Center
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Orange, California, Forenede Stater, 92868
- University of California Irvine Medical Center
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San Francisco, California, Forenede Stater, 94158 2549
- University of California San Francisco
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Torrance, California, Forenede Stater, 90503
- Genesis Research LLC
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Colorado
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Lakewood, Colorado, Forenede Stater, 80228
- Colorado Clinical Research
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Florida
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Riverview, Florida, Forenede Stater, 33578
- Florida Urology Partners
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Chicago Ridge, Illinois, Forenede Stater, 60415
- UroPartners
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Indiana
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Carmel, Indiana, Forenede Stater, 46032
- Urology of Indiana
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Jeffersonville, Indiana, Forenede Stater, 47130
- First Urology, PSC
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Kansas
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Wichita, Kansas, Forenede Stater, 67226
- Wichita Urology Group
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Michigan
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Royal Oak, Michigan, Forenede Stater, 48073
- Comprehensive Urology
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Missouri
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St Louis, Missouri, Forenede Stater, 63141
- Specialty Clinical Research of St Louis
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New York
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Syracuse, New York, Forenede Stater, 13210
- Associated Medical Professionals
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45212
- The Urology Group
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Gahanna, Ohio, Forenede Stater, 43230
- Central Ohio Urology Group
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forenede Stater, 19004
- Centers for Advanced Urology LLC d b a MidLantic Urology
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29401
- Ralph H. Johnson Veterans Affairs Medical Center
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Myrtle Beach, South Carolina, Forenede Stater, 29572
- Carolina Urologic Research Center
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North Charleston, South Carolina, Forenede Stater, 29406
- Low Country Urology Clinics
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center
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Nashville, Tennessee, Forenede Stater, 37209
- Urology Associates
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Texas
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Austin, Texas, Forenede Stater, 78759
- Urology Austin
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Dallas, Texas, Forenede Stater, 75390
- University of Texas Southwestern Medical Center
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Dallas, Texas, Forenede Stater, 75231
- Urology Clinics of North Texas
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Houston, Texas, Forenede Stater, 77027
- Houston Metro Urology
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Washington
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Spokane, Washington, Forenede Stater, 99202
- Spokane Urology
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Lille, Frankrig, 59000
- Hopital Claude Huriez
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Limoges, Frankrig, 87000
- Polyclinique de Limoges - Francois Chenieux
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Marseille, Frankrig, 13009
- Institut Paoli Calmettes
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Paris, Frankrig, 75018
- APHP - Hopital Bichat - Claude Bernard
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Quint-Fonsegrives, Frankrig, 31130
- Clinique de la Croix du Sud
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Rennes, Frankrig, 35000
- Chu Rennes Hopital Pontchaillou
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Suresnes, Frankrig, 92150
- Hopital Foch
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Arezzo, Italien, 52100
- Ospedale San Donato
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Milan, Italien, 20132
- San Raffaele Hospital
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Milan, Italien, 20133
- Istituto Dei Tumori Di Milano
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Province of Macerata, Italien, 62100
- Ospedale Provinciale di Macerata
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Ravenna, Italien, 48121
- Ospedale S. Maria Delle Croci
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Roma, Italien, 00144
- Istituto Nazionale Tumori Regina Elena
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Roma, Italien, 00128
- Universita Campus Bio-Medico di Roma
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Rozzano, Italien, 20089
- Istituto Clinico Humanitas
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Torino, Italien, 10126
- PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
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Funabashi Shi, Japan, 273 8588
- Funabashi Municipal Medical Center
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Hakodate, Japan, 040 8611
- Hakodate Goryoukaku Hospital
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Hyōgo, Japan, 660-8550
- Hyogo Prefectural Amagasaki General Medical Center
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Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Okayama, Japan, 701-1192
- National Hospital Organization Okayama Medical Center
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Sakura, Japan, 285-8741
- Toho University Sakura Medical Center
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Tokyo, Japan, 105-8470
- Toranomon Hospital
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Yokohama, Japan, 232 0024
- Yokohama City University Medical Center
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Beijing, Kina, 100034
- Peking University First Hospital
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Cheng Du Shi, Kina, 610041
- West China School of Medicine/West China Hospital, Sichuan University
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Chongqing, Kina, 400033
- Chongqing Cancer Hospital
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Guangzhou, Kina, 510060
- Sun Yat Sen University Cancer Center
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Shenyang, Kina, 110055
- Shengjing Hospital Of China Medical University
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Tianjin, Kina, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Tianjin, Kina, 300211
- The Second Hospital Of Tianjin Medical University
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Wenzhou, Kina, 325015
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Kina, 430032
- Tongji Medical College of Huazhong University Science Technology of Medicine Health Management
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Xi'an, Kina, 710063
- Xi an Jiaotong University Hospital
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Bialystok, Polen, 15 276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Bydgoszcz, Polen, 85 048
- IN VIVO Sp. z o.o
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Krakow, Polen, 30 688
- Szpital Uniwersytecki w Krakowie
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Lublin, Polen, 20 090
- Uniwersytecki Szpital Kliniczny nr 4
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Przemyśl, Polen, 37 700
- Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
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Tarnów, Polen, 33 100
- Szpital Wojewodzki im Sw Lukasza SP ZOZ
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Torun, Polen, 87-100
- MICS Centrum Medyczne Torun
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Wieliszew, Polen, 05-135
- Mazowiecki Szpital Onkologiczny
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Wroclaw, Polen, 53 413
- Dolnoslaskie Centrum Onkologii
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Brasov, Rumænien, 500091
- Centrul Medical Unirea SRL
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Bucharest, Rumænien, 014142
- Ponderas Academic Hospital
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Cluj-Napoca, Rumænien, 400015
- Institutul Oncologic Ion Chiricuta
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Cluj-Napoca, Rumænien, 400117
- Regina Maria
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Timișoara, Rumænien, 300723
- Spitalul Clinic Judetean de Urgenta Pius Brinzeu
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Badalona, Spanien, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Spanien, 08025
- Fund. Puigvert
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Madrid, Spanien, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spanien, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Málaga, Spanien, 29010
- Hosp Virgen de La Victoria
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Sabadell, Spanien, 08208
- Hosp.Univ.Parc Tauli
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Santander, Spanien, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, Spanien, 41013
- Hosp. Virgen Del Rocio
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Valencia, Spanien, 46010
- Hosp. Clinico Univ. de Valencia
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Chungcheongbuk Do, Sydkorea, 28644
- Chungbuk National University Hospital
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Daegu, Sydkorea, 42601
- Keimyung University Dongsan Hospital
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Gyeonggi-do, Sydkorea, 10408
- National Cancer Center
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Jeollanam-do, Sydkorea, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Sydkorea, 03080
- Seoul National University Hospital
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Seoul, Sydkorea, 06351
- Samsung Medical Center
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Seoul, Sydkorea, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Yangsan, Sydkorea, 50612
- Pusan National University Yangsan Hospital
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Cologne, Tyskland, 50937
- Universitaetsklinikum Koeln
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Halle, Tyskland, 06120
- Universitaetsklinikum Halle Saale
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Leverkusen, Tyskland, 51375
- Klinikum Leverkusen gGmbH
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Lübeck, Tyskland, 23538
- Universitatsklinikum Schleswig Holstein Campus Lubeck
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Mettmann, Tyskland, 40822
- Urologie Neandertal Praxis Mettmann
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München, Tyskland, 81377
- Klinikum der Universitaet Muenchen
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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:
- Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [defined as high-grade Ta or any T1, no carcinoma in situ (CIS)]
- Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded
- Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
Exclusion Criteria:
- Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+)
- Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded
- A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (>4000 mL)
- Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
- Previous treatment with TAR-200
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: Group A: TAR-200
Participants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase. |
Participants will receive TAR-200 intravesically.
Andre navne:
|
|
Aktiv komparator: Group B: Mitomycin C (MMC) or Gemcitabine
Participants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase. |
Participants will receive MMC intravesically. Participants will receive gemcitabine intravesically. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease-free Survival (DFS)
Tidsramme: Up to 6 years 7 months
|
DFS will be measured as the time from randomization to the time of the first recurrence of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [high grade (HG) Ta, any T1 or carcinoma in situ (CIS)], progression, or death due to any cause, whichever occurs first. |
Up to 6 years 7 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence-Free Survival (RFS)
Tidsramme: Up to 6 years 7 months
|
RFS will be measured as the time from randomization to the time of the first recurrence of HR-NMIBC (HG Ta, any T1 or CIS), or death due to any cause, whichever occurs first. |
Up to 6 years 7 months
|
|
Time to Next Intervention (TTNI)
Tidsramme: Up to 6 years 7 months
|
TTNI will be measured as the time from randomization to the time of next intervention (localized or systemic) for the treatment of bladder cancer. |
Up to 6 years 7 months
|
|
Time to Disease Worsening (TTDW)
Tidsramme: Up to 6 years 7 months
|
TTDW is measured as the time from randomization to cystectomy, systemic therapy, or radiation therapy (treatments of disease worsening). |
Up to 6 years 7 months
|
|
Time to Progression (TTP)
Tidsramme: Up to 6 years 7 months
|
TTP will be measured as the time from randomization to the time of first documented evidence of disease progression (that is, progression to muscle-invasive bladder cancer [MIBC] [T greater than or equal to {>=} 2], lymph node disease [N+], or distant disease [M+]), or death due to disease progression, whichever occurs first. |
Up to 6 years 7 months
|
|
Overall Survival (OS)
Tidsramme: Up to 6 years 7 months
|
OS is defined as the time from randomization to death, due to any cause. |
Up to 6 years 7 months
|
|
DFS Rate at 12 and 24 Months
Tidsramme: At 12 and 24 months
|
DFS rate that is percentage of participants with DFS at 12 and 24 months will be reported. |
At 12 and 24 months
|
|
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)
Tidsramme: Up to 6 years 7 months
|
Number of participants with AEs by severity grade as assessed by CTCAE version 5 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event. |
Up to 6 years 7 months
|
|
Number of Participants With Change from Baseline in Laboratory Abnormalities
Tidsramme: Up to 6 years 7 months
|
Number of participants with change from baseline in laboratory abnormalities (including hematology, clinical chemistry and routine urinalysis) will be reported. |
Up to 6 years 7 months
|
|
Number of Participants With Change from Baseline in Vital Signs Abnormalities
Tidsramme: Up to 6 years 7 months
|
Number of participants with change from baseline in vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure (systolic and diastolic) (supine) will be reported. |
Up to 6 years 7 months
|
|
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) - C30 Scores
Tidsramme: Up to 5 years
|
EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much). |
Up to 5 years
|
|
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Tidsramme: Up to 5 years
|
EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much). |
Up to 5 years
|
|
Proportion of Participants With Meaningful Change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 Scores
Tidsramme: Up to 5 years
|
Proportion of participants with meaningful change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 scores will be reported. |
Up to 5 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical trial, Janssen Research & Development, LLC
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
- Urinblære neoplasmer
- Ikke-muskelinvasive blære-neoplasmer
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Indoler
- Deoxycytidin
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Quinones
- Aziriner
- Mitomycins
- Indolequinones
- Gemcitabin
- Mitomycin
Andre undersøgelses-id-numre
- 17000139BLC3004
- 17000139BLC3004 (Anden identifikator: Janssen Research & Development, LLC)
- 2023-507685-10-00 (Registry Identifier: EUCT number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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