A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Interventions
- Registration Number
- NCT06319820
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 540
- Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor >= 3 cm, iii. Early recurrence (less than [<] 1 year), iv. Frequent recurrence (greater than [>] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
- Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
- Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.
- Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
- Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
- Have an Eastern Cooperative Oncology Group performance status of 0 to 2
- Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs
- Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy
- Polyuria with recorded 24-hour urine volumes > 4000 milliliters (mL)
- Current indwelling urinary catheters, however, intermittent catheterization is acceptable
- Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: TAR-210 TAR-210 Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year. Group B: MMC or Gemcitabine Gemcitabine Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year. Group B: MMC or Gemcitabine MMC Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
- Primary Outcome Measures
Name Time Method Disease Free Survival (DFS) From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months) DFS is measured as the time from randomization to the date of the first documented recurrence of non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Time to next Treatment (TTNT) From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months) TTNT is measured as the time from randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer.
High Grade Recurrence-free Survival (HG RFS) From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months) HG RFS is measured as the time from randomization to the date of first documented evidence of HG NMIBC or death, whichever occurs first
Progression Free Survival (PFS) From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months) PFS is measured as the time from randomization to the date of first documented evidence of disease progression or death, whichever occurs first.
Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment From study treatment completion up to trial discontinuation (approximately 4 years and 2 months) Rate of diagnostic and therapeutic invasive urological interventions after study treatment, that is, endoscopic procedures (e.g., cystoscopies, transurethral resection of bladder tumors (TURBTs), ureteroscopies, urethral interventions, urethral stricture/bladder neck incision), catheterization (intravesical, suprapubic), intravesical treatments, major surgeries (e.g., radical cystectomy, simple cystectomy, urethroplasty) will be reported.
Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities) From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months) An AE is any untoward medical occurrence in a participant participating in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product, that does not necessarily have a causal relationship with the treatment. AEs will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening and Grade 5: Death. Number of participants with adverse events (including physical examination, vital signs and laboratory abnormalities) will be reported.
Overall Survival (OS) From randomization to the date of death (approximately 4 years and 2 months) OS is defined as the time from randomization to the date of death from any cause.
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores Baseline, Weeks 6, 12, 24, 36, and 48 EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 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). Higher scores indicated greater severity.
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores Baseline, Weeks 6, 12, 24, 36, and 48 EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.
Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores Weeks 6, 12, 24, 36, and 48 EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the HRQoL of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 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). Higher scores indicated greater severity.
Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores Weeks 6, 12, 24, 36, and 48 EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.
Related Research Topics
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Trial Locations
- Locations (190)
Adelaide and Meath Hospital
🇮🇪Dublin, Ireland
National Cancer Center
🇰🇷Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
IN VIVO Sp. z o.o
🇵🇱Bydgoszcz, Poland
Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Uniwersytecki Szpital Kliniczny nr 4
🇵🇱Lublin, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
🇵🇱Przemysl, Poland
Charing Cross Hospital
🇬🇧London, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Colorado Clinical Research
🇺🇸Lakewood, Colorado, United States
Mater Private Hospital
🇮🇪Dublin, Ireland
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
Genesis Research LLC
🇺🇸Sherman Oaks, California, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
University of California Irvine Medical Center
🇺🇸Orange, California, United States
Genesis Research
🇺🇸San Diego, California, United States
University of Colorado Cancer Center Anschultz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
First Urology
🇺🇸Jeffersonville, Indiana, United States
Wichita Urology Group
🇺🇸Wichita, Kansas, United States
Ochsner Health System
🇺🇸New Orleans, Louisiana, United States
Chesapeake Urology Research Associates
🇺🇸Hanover, Maryland, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Comprehensive Urology
🇺🇸Royal Oak, Michigan, United States
Mercy Research
🇺🇸Saint Louis, Missouri, United States
Specialty Clinical Research of St Louis
🇺🇸Saint Louis, Missouri, United States
The Urology Center, PC
🇺🇸Omaha, Nebraska, United States
Cancer Institute Of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Integrated Medical Professionals
🇺🇸New York, New York, United States
Associated Medical Professionals of Ny
🇺🇸Syracuse, New York, United States
SUNY Upstate Med Univ
🇺🇸Syracuse, New York, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Associated Urologists of North Carolina
🇺🇸Raleigh, North Carolina, United States
MidLantic Urology
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Keystone Urology Specialists
🇺🇸Lancaster, Pennsylvania, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
The Conrad Pearson Clinic
🇺🇸Germantown, Tennessee, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Urology Associates
🇺🇸Nashville, Tennessee, United States
Urology Austin
🇺🇸Austin, Texas, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Houston Metro Urology
🇺🇸Houston, Texas, United States
Spokane Urology
🇺🇸Spokane, Washington, United States
Investigaciones Clinico Moleculares (ICM)
🇦🇷Caba, Argentina
Hospital Sirio Libanes
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
🇦🇷Cordoba, Argentina
Centro Urologico Profesor Bengio
🇦🇷Cordoba, Argentina
Hospital Privado de la Comunidad
🇦🇷Mar del Plata, Argentina
Sanatorio de la Mujer
🇦🇷Rosario, Argentina
Medizinische Universitaet Graz
🇦🇹Graz, Austria
Medizinische Universitat Innsbruck
🇦🇹Innsbruck, Austria
Ordensklinikum Linz GmbH Elisabethinen
🇦🇹Linz, Austria
Universitaetsklinikum Salzburg Landeskrankenhaus
🇦🇹Salzburg, Austria
Medical University Vienna MUV
🇦🇹Wien, Austria
Onze -Lieve-Vrouwziekenhuis
🇧🇪Aalst, Belgium
AZ Sint-Jan
🇧🇪Brugge, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
Universitair Ziekenhuis Gasthuisberg
🇧🇪Leuven, Belgium
Vitaz
🇧🇪Sint Niklaas, Belgium
CHU UCL Namur - Site Godinne
🇧🇪Yvoir, Belgium
Fundacao Pio XII
🇧🇷Barretos, Brazil
Universidade Estadual De Campinas
🇧🇷Campinas, Brazil
Liga Norte Riograndense Contra O Cancer
🇧🇷Natal, Brazil
Associacao Hospitalar Moinhos de Vento
🇧🇷Porto Alegre, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Brazil
HBA SA Assitencia Medica e Hospitalar
🇧🇷Salvador, Brazil
Fundacao do ABC Centro Universitario FMABC
🇧🇷Santo Andre, Brazil
Herlev Hospital
🇩🇰Herlev, Denmark
Irmandade Da Santa Casa De Misericordia De Sao Paulo
🇧🇷Sao Paulo, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
🇧🇷Sao Paulo, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
🇧🇷Sao Paulo, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
🇧🇷Sao Paulo, Brazil
Beijing Friendship Hospital Capital Medical University
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
Hunan Cancer hospital
🇨🇳Changsha, China
The Third People's Hospital of Chengdu
🇨🇳Cheng Du Shi, China
West China School of Medicine/West China Hospital, Sichuan University
🇨🇳Cheng Du Shi, China
Chongqing Cancer Hospital
🇨🇳Chong Qing, China
Fujian Medical University Union Hospital
🇨🇳Fu Zhou Shi, China
Sun Yat Sen University Cancer Center
🇨🇳Guang Zhou Shi, China
Nanjing Drum Tower Hospital
🇨🇳Nan Jing Shi, China
Zhongda Hospital Southeast University
🇨🇳Nan Jing Shi, China
Huadong Hospital Affiliated to Fudan University
🇨🇳Shanghai, China
The Second Hospital Of Tianjin Medical University
🇨🇳Tianjin, China
Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wu Han Shi, China
The First Affiliated Hospital of Xian Jiaotong University
🇨🇳XI An Shi, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, China
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Fakultni Thomayerova nemocnice
🇨🇿Praha 4, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha, Czechia
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Rigshospitalet
🇩🇰Kobenhavn, Denmark
Odense Universitetshospital
🇩🇰Odense, Denmark
Zealand University Hospital
🇩🇰Roskilde, Denmark
Hospital Center University De Lille
🇫🇷Lille, France
Polyclinique de Limoges - Francois Chenieux
🇫🇷Limoges, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
Institut Paoli Calmettes
🇫🇷Marseille, France
Hopital Saint Louis
🇫🇷Paris, France
CHU Pitie Salpetriere
🇫🇷Paris, France
APHP - Hopital Bichat - Claude Bernard
🇫🇷Paris, France
Clinique de la Croix du Sud
🇫🇷Quint-Fonsegrives, France
Chu Rennes Hopital Pontchaillou
🇫🇷Rennes, France
CHU Rangueil
🇫🇷Toulouse, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Charite - Universitaetsmedizin Berlin (CCM)
🇩🇪Berlin, Germany
Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
🇩🇪Braunschweig, Germany
Urologische Gemeinschaftspraxis
🇩🇪Dresden, Germany
Universitaetsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Urologikum Hamburg MVZ - Germany
🇩🇪Hamburg, Germany
Marien hospital Herne
🇩🇪Herne, Germany
Universitatsklinikum Jena
🇩🇪Jena, Germany
Studienzentrum Bayenthal
🇩🇪Koeln, Germany
Klinikum rechts der Isar an der Technischen Universitat Munchen
🇩🇪Munchen, Germany
Klinikum St. Elisabeth Straubing GmbH
🇩🇪Straubing, Germany
Katharinenhospital Innere Medizin
🇩🇪Stuttgart, Germany
Prince Of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Cork University Hospital
🇮🇪Cork, Ireland
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Rambam Health Care Campus
🇮🇱Haifa, Israel
Hadassah University Hospita Ein Kerem
🇮🇱Jerusalem, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Ziv Medical Center
🇮🇱Safed, Israel
Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica
🇮🇹Arezzo, Italy
Cliniche Humanitas Gavazzeni
🇮🇹Bergamo, Italy
ASST Spedali Civili Brescia
🇮🇹Brescia, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Istituto Dei Tumori Di Milano
🇮🇹Milano, Italy
Universita Campus Bio-Medico di Roma
🇮🇹Roma, Italy
Istituto Nazionale Tumori Regina Elena
🇮🇹Roma, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
A.O.Citta della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Hyogo Prefectural Amagasaki General Medical Center
🇯🇵Amagasaki shi, Japan
St Marianna University Hospital
🇯🇵Kawasaki Shi, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe City, Japan
National Hospital Organization Kumamoto Medical Center
🇯🇵Kumamoto City, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota, Japan
Saitama Medical Center
🇯🇵Saitama, Japan
JRC Wakayama Medical Center
🇯🇵Wakayama, Japan
Yokohama Municipal Citizen's Hospital
🇯🇵Yokohama, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Japan
Yokosuka Kyosai Hospital
🇯🇵Yokosuka, Japan
Chungbuk National University Hospital
🇰🇷Chungcheongbuk Do, Korea, Republic of
Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
🇵🇱Tarnow, Poland
Medicover Integrated Clinical Services Sp z o o
🇵🇱Torun, Poland
Mazowiecki Szpital Onkologiczny Sp z o o
🇵🇱Wieliszew, Poland
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
🇵🇱Wroclaw, Poland
Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii
🇵🇱Wroclaw, Poland
Hosp Univ A Coruna
🇪🇸A Coruna, Spain
Hosp. Univ. de La Ribera
🇪🇸Alzira, Spain
Fund. Puigvert
🇪🇸Barcelona, Spain
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Hosp. Puerta Del Mar
🇪🇸Cadiz, Spain
Hosp. Gral. Univ. de Castellon
🇪🇸Castellon, Spain
Hosp. de Jerez de La Frontera
🇪🇸Jerez De La Frontera, Spain
Hosp. Gral. Univ. Gregorio Maranon
🇪🇸Madrid, Spain
Clinica Univ. de Navarra
🇪🇸Madrid, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Hosp Virgen de La Victoria
🇪🇸Malaga, Spain
Hosp. Univ. Central de Asturias
🇪🇸Oviedo, Spain
Hosp.Univ.Parc Tauli
🇪🇸Sabadell, Spain
Hosp. Virgen Del Rocio
🇪🇸Sevilla, Spain
Hosp. Clinico Univ. de Valencia
🇪🇸Valencia, Spain
Adana Baskent Practice and Research Hospital
🇹🇷Adana, Turkey
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
🇹🇷Ankara, Turkey
Istanbul University Cerrahpasa Medical Faculty
🇹🇷Istanbul, Turkey
T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
🇹🇷Istanbul, Turkey
Kartal Dr Lutfi Kirdar sehir Hastanesi
🇹🇷Istanbul, Turkey
Dokuz Eylul University Medical Faculty
🇹🇷Izmir, Turkey
St Bartholomews Hospital
🇬🇧London, United Kingdom
Newcastle Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Southmead Hospital
🇬🇧Bristol, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom