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| ID | Type | Description | Link |
|---|---|---|---|
| 17000139BLC3004 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-507685-10-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: TAR-200 | Experimental | Participants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase. |
|
| Group B: Mitomycin C (MMC) or Gemcitabine | Active Comparator | Participants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAR-200 | Drug | Participants will receive TAR-200 intravesically. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free Survival (RFS) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Urology | Little Rock | Arkansas | 72211 | United States | ||
| Genesis Research LLC 1 |
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.
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| Mitomycin C | Drug | Participants will receive MMC intravesically. |
|
| Gemcitabine | Drug | Participants will receive gemcitabine intravesically. |
|
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) | 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) | 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) | 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 | 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) | 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 | 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 | 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 | 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 | 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 | Proportion of participants with meaningful change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 scores will be reported. | Up to 5 years |
| Los Alamitos |
| California |
| 90720 |
| United States |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
| University of California San Francisco | San Francisco | California | 94158 2549 | United States |
| Genesis Research LLC | Torrance | California | 90503 | United States |
| Colorado Clinical Research | Lakewood | Colorado | 80228 | United States |
| Florida Urology Partners | Riverview | Florida | 33578 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| UroPartners | Chicago Ridge | Illinois | 60415 | United States |
| Urology of Indiana | Carmel | Indiana | 46032 | United States |
| First Urology, PSC | Jeffersonville | Indiana | 47130 | United States |
| Wichita Urology Group | Wichita | Kansas | 67226 | United States |
| Comprehensive Urology | Royal Oak | Michigan | 48073 | United States |
| Specialty Clinical Research of St Louis | St Louis | Missouri | 63141 | United States |
| Associated Medical Professionals | Syracuse | New York | 13210 | United States |
| The Urology Group | Cincinnati | Ohio | 45212 | United States |
| Central Ohio Urology Group | Gahanna | Ohio | 43230 | United States |
| Centers for Advanced Urology LLC d b a MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Ralph H. Johnson Veterans Affairs Medical Center | Charleston | South Carolina | 29401 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Low Country Urology Clinics | North Charleston | South Carolina | 29406 | United States |
| Urology Associates | Nashville | Tennessee | 37209 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Urology Austin | Austin | Texas | 78759 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Houston Metro Urology | Houston | Texas | 77027 | United States |
| Spokane Urology | Spokane | Washington | 99202 | United States |
| Clinica Santa Isabel | Buenos Aires | C1406 | Argentina |
| Investigaciones Clinico Moleculares (ICM) | CABA | C1425 | Argentina |
| Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Córdoba | 5000 | Argentina |
| Centro Urologico Profesor Bengio | Córdoba | X5000KPH | Argentina |
| Hospital Privado de la Comunidad | Mar del Plata | B7602 | Argentina |
| AZ Sint-Jan | Bruges | 8000 | Belgium |
| Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
| Algemeen ziekenhuis Maria Middelares | Ghent | 9000 | Belgium |
| Algemeen Ziekenhuis Delta | Roeselare | 8800 | Belgium |
| Fundacao Pio XII | Barretos | 14784-400 | Brazil |
| NAIC Nair Antunes Instituto do Cancer | Bauru | 17030-495 | Brazil |
| Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP | Campinas | 13083-872 | Brazil |
| Liga Paranaense de Combate ao Cancer | Curitiba | 81520 060 | Brazil |
| Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | 90020-090 | Brazil |
| Hospital da Bahia | Salvador | 41810-011 | Brazil |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes | São Paulo | 01308 901 | Brazil |
| Real e Benemérita Associação Portuguesa de Beneficência | São Paulo | 01323 900 | Brazil |
| Fundacao Antonio Prudente A C Camargo Cancer Center | São Paulo | 01509 900 | Brazil |
| Peking University First Hospital | Beijing | 100034 | China |
| West China School of Medicine/West China Hospital, Sichuan University | Cheng Du Shi | 610041 | China |
| Chongqing Cancer Hospital | Chongqing | 400033 | China |
| Sun Yat Sen University Cancer Center | Guangzhou | 510060 | China |
| Shengjing Hospital Of China Medical University | Shenyang | 110055 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | 300060 | China |
| The Second Hospital Of Tianjin Medical University | Tianjin | 300211 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | 325015 | China |
| Tongji Medical College of Huazhong University Science Technology of Medicine Health Management | Wuhan | 430032 | China |
| Xi an Jiaotong University Hospital | Xi'an | 710063 | China |
| Hopital Claude Huriez | Lille | 59000 | France |
| Polyclinique de Limoges - Francois Chenieux | Limoges | 87000 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| APHP - Hopital Bichat - Claude Bernard | Paris | 75018 | France |
| Clinique de la Croix du Sud | Quint-Fonsegrives | 31130 | France |
| Chu Rennes Hopital Pontchaillou | Rennes | 35000 | France |
| Hopital Foch | Suresnes | 92150 | France |
| Universitaetsklinikum Koeln | Cologne | 50937 | Germany |
| Universitaetsklinikum Halle Saale | Halle | 06120 | Germany |
| Klinikum Leverkusen gGmbH | Leverkusen | 51375 | Germany |
| Universitatsklinikum Schleswig Holstein Campus Lubeck | Lübeck | 23538 | Germany |
| Urologie Neandertal Praxis Mettmann | Mettmann | 40822 | Germany |
| Klinikum der Universitaet Muenchen | München | 81377 | Germany |
| Ospedale San Donato | Arezzo | 52100 | Italy |
| San Raffaele Hospital | Milan | 20132 | Italy |
| Istituto Dei Tumori Di Milano | Milan | 20133 | Italy |
| Ospedale Provinciale di Macerata | Province of Macerata | 62100 | Italy |
| Ospedale S. Maria Delle Croci | Ravenna | 48121 | Italy |
| Universita Campus Bio-Medico di Roma | Roma | 00128 | Italy |
| Istituto Nazionale Tumori Regina Elena | Roma | 00144 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Funabashi Municipal Medical Center | Funabashi Shi | 273 8588 | Japan |
| Hakodate Goryoukaku Hospital | Hakodate | 040 8611 | Japan |
| Hyogo Prefectural Amagasaki General Medical Center | Hyōgo | 660-8550 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | 701-1192 | Japan |
| Toho University Sakura Medical Center | Sakura | 285-8741 | Japan |
| Toranomon Hospital | Tokyo | 105-8470 | Japan |
| Yokohama City University Medical Center | Yokohama | 232 0024 | Japan |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | 15 276 | Poland |
| IN VIVO Sp. z o.o | Bydgoszcz | 85 048 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 30 688 | Poland |
| Uniwersytecki Szpital Kliniczny nr 4 | Lublin | 20 090 | Poland |
| Wojewodzki Szpital im Sw Ojca Pio w Przemyslu | Przemyśl | 37 700 | Poland |
| Szpital Wojewodzki im Sw Lukasza SP ZOZ | Tarnów | 33 100 | Poland |
| MICS Centrum Medyczne Torun | Torun | 87-100 | Poland |
| Mazowiecki Szpital Onkologiczny | Wieliszew | 05-135 | Poland |
| Dolnoslaskie Centrum Onkologii | Wroclaw | 53 413 | Poland |
| Centrul Medical Unirea SRL | Brasov | 500091 | Romania |
| Ponderas Academic Hospital | Bucharest | 014142 | Romania |
| Institutul Oncologic Ion Chiricuta | Cluj-Napoca | 400015 | Romania |
| Regina Maria | Cluj-Napoca | 400117 | Romania |
| Spitalul Clinic Judetean de Urgenta Pius Brinzeu | Timișoara | 300723 | Romania |
| Chungbuk National University Hospital | Chungcheongbuk Do | 28644 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Mary s Hospital | Seoul | 06591 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | 50612 | South Korea |
| Hosp. Univ. Germans Trias I Pujol | Badalona | 08916 | Spain |
| Fund. Puigvert | Barcelona | 08025 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | 28007 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp Virgen de La Victoria | Málaga | 29010 | Spain |
| Hosp.Univ.Parc Tauli | Sabadell | 08208 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| Hosp. Virgen Del Rocio | Seville | 41013 | Spain |
| Hosp. Clinico Univ. de Valencia | Valencia | 46010 | Spain |
| St Bartholomews Hospital | London | EC1A 7BE | United Kingdom |
| Salford Royal Hospital | Salford | M6 8HD | United Kingdom |
| Southampton University Hospital | Southampton | SO16 6YD | United Kingdom |
| Lister Hospital | Stevenage | SG1 4AB | United Kingdom |
| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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