Un estudio de TAR-200 versus quimioterapia intravesical en participantes con cáncer de vejiga no invasivo muscular de alto riesgo recurrente (HR-NMIBC) después del bacilo de Calmette-Guérin (BCG) (SunRISe-5)
Un estudio de fase 3, aleatorizado, abierto y multicéntrico que evalúa la eficacia y seguridad de TAR-200 frente a la quimioterapia intravesical elegida por el investigador en participantes que recibieron bacilo de Calmette-Guérin (BCG) y recurrieron con tratamientos no musculares de alto riesgo. Cáncer de vejiga invasivo (HR-NMIBC) y que no son elegibles o eligen no someterse a una cistectomía radical
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Cologne, Alemania, 50937
- Universitaetsklinikum Koeln
-
Halle, Alemania, 06120
- Universitaetsklinikum Halle Saale
-
Leverkusen, Alemania, 51375
- Klinikum Leverkusen gGmbH
-
Lübeck, Alemania, 23538
- Universitatsklinikum Schleswig Holstein Campus Lubeck
-
Mettmann, Alemania, 40822
- Urologie Neandertal Praxis Mettmann
-
München, Alemania, 81377
- Klinikum der Universitaet Muenchen
-
-
-
-
-
Buenos Aires, Argentina, C1406
- Clinica Santa Isabel
-
CABA, Argentina, C1425
- Investigaciones Clinico Moleculares (ICM)
-
Córdoba, Argentina, 5000
- Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
-
Córdoba, Argentina, X5000KPH
- Centro Urologico Profesor Bengio
-
Mar del Plata, Argentina, B7602
- Hospital Privado de la Comunidad
-
-
-
-
-
Barretos, Brasil, 14784-400
- Fundacao Pio XII
-
Bauru, Brasil, 17030-495
- NAIC Nair Antunes Instituto do Cancer
-
Campinas, Brasil, 13083-872
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
-
Curitiba, Brasil, 81520-060
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
-
Porto Alegre, Brasil, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
-
Salvador, Brasil, 41810-011
- Hospital da Bahia
-
São Paulo, Brasil, 01308 901
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes
-
São Paulo, Brasil, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
-
São Paulo, Brasil, 01323 900
- Real e Benemérita Associação Portuguesa de Beneficência
-
-
-
-
-
Bruges, Bélgica, 8000
- AZ Sint-Jan
-
Brussels, Bélgica, 1200
- Cliniques Universitaires Saint Luc
-
Genk, Bélgica, 3600
- Ziekenhuis Oost-Limburg
-
Ghent, Bélgica, 9000
- Algemeen ziekenhuis Maria Middelares
-
Roeselare, Bélgica, 8800
- Algemeen Ziekenhuis Delta
-
-
-
-
-
Chungcheongbuk Do, Corea del Sur, 28644
- Chungbuk National University Hospital
-
Daegu, Corea del Sur, 42601
- Keimyung University Dongsan Hospital
-
Gyeonggi-do, Corea del Sur, 10408
- National Cancer Center
-
Jeollanam-do, Corea del Sur, 58128
- Chonnam National University Hwasun Hospital
-
Seoul, Corea del Sur, 03080
- Seoul National University Hospital
-
Seoul, Corea del Sur, 06351
- Samsung Medical Center
-
Seoul, Corea del Sur, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
-
Yangsan, Corea del Sur, 50612
- Pusan National University Yangsan Hospital
-
-
-
-
-
Badalona, España, 08916
- Hosp. Univ. Germans Trias I Pujol
-
Barcelona, España, 08025
- Fund. Puigvert
-
Madrid, España, 28041
- Hosp. Univ. 12 de Octubre
-
Madrid, España, 28007
- Hosp. Gral. Univ. Gregorio Maranon
-
Málaga, España, 29010
- Hosp Virgen de La Victoria
-
Sabadell, España, 08208
- Hosp.Univ.Parc Tauli
-
Santander, España, 39008
- Hosp. Univ. Marques de Valdecilla
-
Seville, España, 41013
- Hosp. Virgen Del Rocio
-
Valencia, España, 46010
- Hosp. Clinico Univ. de Valencia
-
-
-
-
Arkansas
-
Little Rock, Arkansas, Estados Unidos, 72211
- Arkansas Urology
-
-
California
-
Los Alamitos, California, Estados Unidos, 90720
- Genesis Research LLC 1
-
Los Angeles, California, Estados Unidos, 90033
- USC Norris Comprehensive Cancer Center
-
Orange, California, Estados Unidos, 92868
- University of California Irvine Medical Center
-
San Francisco, California, Estados Unidos, 94158 2549
- University of California San Francisco
-
Torrance, California, Estados Unidos, 90503
- Genesis Research LLC
-
-
Colorado
-
Lakewood, Colorado, Estados Unidos, 80228
- Colorado Clinical Research
-
-
Florida
-
Riverview, Florida, Estados Unidos, 33578
- Florida Urology Partners
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
-
Chicago Ridge, Illinois, Estados Unidos, 60415
- UroPartners
-
-
Indiana
-
Carmel, Indiana, Estados Unidos, 46032
- Urology of Indiana
-
Jeffersonville, Indiana, Estados Unidos, 47130
- First Urology, PSC
-
-
Kansas
-
Wichita, Kansas, Estados Unidos, 67226
- Wichita Urology Group
-
-
Michigan
-
Royal Oak, Michigan, Estados Unidos, 48073
- Comprehensive Urology
-
-
Missouri
-
St Louis, Missouri, Estados Unidos, 63141
- Specialty Clinical Research of St Louis
-
-
New York
-
Syracuse, New York, Estados Unidos, 13210
- Associated Medical Professionals
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45212
- The Urology Group
-
Gahanna, Ohio, Estados Unidos, 43230
- Central Ohio Urology Group
-
-
Pennsylvania
-
Bala-Cynwyd, Pennsylvania, Estados Unidos, 19004
- Centers for Advanced Urology LLC d b a MidLantic Urology
-
-
South Carolina
-
Charleston, South Carolina, Estados Unidos, 29401
- Ralph H. Johnson Veterans Affairs Medical Center
-
Myrtle Beach, South Carolina, Estados Unidos, 29572
- Carolina Urologic Research Center
-
North Charleston, South Carolina, Estados Unidos, 29406
- Low Country Urology Clinics
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
-
Nashville, Tennessee, Estados Unidos, 37209
- Urology Associates
-
-
Texas
-
Austin, Texas, Estados Unidos, 78759
- Urology Austin
-
Dallas, Texas, Estados Unidos, 75390
- University of Texas Southwestern Medical Center
-
Dallas, Texas, Estados Unidos, 75231
- Urology Clinics of North Texas
-
Houston, Texas, Estados Unidos, 77027
- Houston Metro Urology
-
-
Washington
-
Spokane, Washington, Estados Unidos, 99202
- Spokane Urology
-
-
-
-
-
Lille, Francia, 59000
- Hopital Claude Huriez
-
Limoges, Francia, 87000
- Polyclinique de Limoges - Francois Chenieux
-
Marseille, Francia, 13009
- Institut Paoli Calmettes
-
Paris, Francia, 75018
- APHP - Hopital Bichat - Claude Bernard
-
Quint-Fonsegrives, Francia, 31130
- Clinique de la Croix du Sud
-
Rennes, Francia, 35000
- Chu Rennes Hopital Pontchaillou
-
Suresnes, Francia, 92150
- Hopital Foch
-
-
-
-
-
Arezzo, Italia, 52100
- Ospedale San Donato
-
Milan, Italia, 20132
- San Raffaele Hospital
-
Milan, Italia, 20133
- Istituto Dei Tumori Di Milano
-
Province of Macerata, Italia, 62100
- Ospedale Provinciale di Macerata
-
Ravenna, Italia, 48121
- Ospedale S. Maria Delle Croci
-
Roma, Italia, 00144
- Istituto Nazionale Tumori Regina Elena
-
Roma, Italia, 00128
- Universita Campus Bio-Medico di Roma
-
Rozzano, Italia, 20089
- Istituto Clinico Humanitas
-
Torino, Italia, 10126
- PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
-
-
-
-
-
Funabashi Shi, Japón, 273 8588
- Funabashi Municipal Medical Center
-
Hakodate, Japón, 040 8611
- Hakodate Goryoukaku Hospital
-
Hyōgo, Japón, 660-8550
- Hyogo Prefectural Amagasaki General Medical Center
-
Niigata, Japón, 951-8566
- Niigata Cancer Center Hospital
-
Okayama, Japón, 701-1192
- National Hospital Organization Okayama Medical Center
-
Sakura, Japón, 285-8741
- Toho University Sakura Medical Center
-
Tokyo, Japón, 105-8470
- Toranomon Hospital
-
Yokohama, Japón, 232 0024
- Yokohama City University Medical Center
-
-
-
-
-
Bialystok, Polonia, 15 276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
Bydgoszcz, Polonia, 85 048
- IN VIVO Sp. z o.o
-
Krakow, Polonia, 30 688
- Szpital Uniwersytecki w Krakowie
-
Lublin, Polonia, 20 090
- Uniwersytecki Szpital Kliniczny nr 4
-
Przemyśl, Polonia, 37 700
- Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
-
Tarnów, Polonia, 33 100
- Szpital Wojewodzki im Sw Lukasza SP ZOZ
-
Torun, Polonia, 87-100
- MICS Centrum Medyczne Torun
-
Wieliszew, Polonia, 05-135
- Mazowiecki Szpital Onkologiczny
-
Wroclaw, Polonia, 53 413
- Dolnoslaskie Centrum Onkologii
-
-
-
-
-
Beijing, Porcelana, 100034
- Peking University First Hospital
-
Cheng Du Shi, Porcelana, 610041
- West China School of Medicine/West China Hospital, Sichuan University
-
Chongqing, Porcelana, 400033
- Chongqing Cancer Hospital
-
Guangzhou, Porcelana, 510060
- Sun Yat Sen University Cancer Center
-
Shenyang, Porcelana, 110055
- Shengjing Hospital Of China Medical University
-
Tianjin, Porcelana, 300060
- Tianjin Medical University Cancer Institute and Hospital
-
Tianjin, Porcelana, 300211
- The Second Hospital Of Tianjin Medical University
-
Wenzhou, Porcelana, 325015
- The First Affiliated Hospital of Wenzhou Medical University
-
Wuhan, Porcelana, 430032
- Tongji Medical College of Huazhong University Science Technology of Medicine Health Management
-
Xi'an, Porcelana, 710063
- Xi an Jiaotong University Hospital
-
-
-
-
-
London, Reino Unido, EC1A 7BE
- St Bartholomews Hospital
-
Salford, Reino Unido, M6 8HD
- Salford Royal Hospital
-
Southampton, Reino Unido, SO16 6YD
- Southampton University Hospital
-
Stevenage, Reino Unido, SG1 4AB
- Lister Hospital
-
-
-
-
-
Brasov, Rumania, 500091
- Centrul Medical Unirea SRL
-
Bucharest, Rumania, 014142
- Ponderas Academic Hospital
-
Cluj-Napoca, Rumania, 400015
- Institutul Oncologic Ion Chiricuta
-
Cluj-Napoca, Rumania, 400117
- Regina Maria
-
Timișoara, Rumania, 300723
- Spitalul Clinic Judetean de Urgenta Pius Brinzeu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
|
|
Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Disease-free Survival (DFS)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Recurrence-Free Survival (RFS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Neoplasias Urológicas
- Carcinoma
- Enfermedades de la vejiga urinaria
- Neoplasias de la vejiga urinaria
- Neoplasias vesicales sin invasión muscular
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Indoles
- Desoxicitidina
- Citidina
- Nucleósidos de pirimidina
- Pirimidinas
- Quinones
- Azirines
- Mitomicinas
- Indolequinonas
- Gemcitabina
- Mitomicina
Otros números de identificación del estudio
- 17000139BLC3004
- 17000139BLC3004 (Otro identificador: Janssen Research & Development, LLC)
- 2023-507685-10-00 (Identificador de registro: EUCT number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .