A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
NCT ID: NCT06319820
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
560 participants
INTERVENTIONAL
2024-04-18
2028-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: 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.
TAR-210
TAR-210 will be administered intravesically.
Group B: MMC or 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.
Gemcitabine
Gemcitabine will be administered intravesically.
MMC
MMC will be administered intravesically.
Interventions
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TAR-210
TAR-210 will be administered intravesically.
Gemcitabine
Gemcitabine will be administered intravesically.
MMC
MMC will be administered intravesically.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Enterprise Innovation Inc. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Enterprise Innovation Inc.
Locations
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Arkansas Urology
Little Rock, Arkansas, United States
Genesis Research LLC
Los Alamitos, 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
Genesis Research LLC
Sherman Oaks, California, United States
University of Colorado Cancer Center Anschultz Cancer Pavilion
Aurora, Colorado, United States
Colorado Clinical Research
Lakewood, 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
Brigham And Women's Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Comprehensive Urology
Royal Oak, Michigan, United States
Mercy Research
St Louis, Missouri, United States
Specialty Clinical Research of St Louis
St 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
Memorial Sloan Kettering Cancer Center
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
Hospital Sirio Libanes
Buenos Aires, , Argentina
Investigaciones Clinico Moleculares (ICM)
CABA, , Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, , Argentina
Centro Urologico Profesor Bengio
Córdoba, , 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
Vienna, , Austria
Onze -Lieve-Vrouwziekenhuis
Aalst, , Belgium
AZ Sint-Jan
Bruges, , Belgium
UZ Antwerpen
Edegem, , Belgium
AZ Maria Middelares
Ghent, , 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 André, , Brazil
Irmandade Da Santa Casa De Misericordia De Sao Paulo
São Paulo, , Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, , Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, , Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São 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
Chongqing, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Sun Yat Sen University Cancer Center
Guangzhou, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Zhongda Hospital Southeast University
Nanjing, , China
Huadong Hospital Affiliated to Fudan University
Shanghai, , China
The Second Hospital Of Tianjin Medical University
Tianjin, , China
Cancer Hospital of Xinjiang Medical University
Ürümqi, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, , China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, , China
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni Thomayerova nemocnice
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev Hospital
Herlev, , 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
Studienzentrum Bayenthal
Cologne, , 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
Klinikum rechts der Isar an der Technischen Universitat Munchen
München, , Germany
Klinikum St. Elisabeth Straubing GmbH
Straubing, , Germany
Katharinenhospital Innere Medizin
Stuttgart, , Germany
Prince Of Wales Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Cork University Hospital
Cork, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
Mater Private Hospital
Dublin, , Ireland
Adelaide and Meath 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
Milan, , Italy
Istituto Dei Tumori Di Milano
Milan, , 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, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Gunma Prefectural Cancer Center
Ōta-ku, , 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
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
Przemyśl, , Poland
Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
Tarnów, , 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
Chungbuk National University Hospital
Chungcheongbuk Do, , South Korea
National Cancer Center
Gyeonggi-do, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hosp Univ A Coruna
A Coruña, , 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
Málaga, , Spain
Hosp. Univ. Central de Asturias
Oviedo, , Spain
Hosp.Univ.Parc Tauli
Sabadell, , Spain
Hosp. Virgen Del Rocio
Seville, , Spain
Hosp. Clinico Univ. de Valencia
Valencia, , Spain
Adana Baskent Practice and Research Hospital
Adana, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Kartal Dr Lutfi Kirdar sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, , Turkey (Türkiye)
Southmead Hospital
Bristol, , United Kingdom
St Bartholomews Hospital
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Newcastle Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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42756493BLC3004
Identifier Type: OTHER
Identifier Source: secondary_id
42756493BLC3004
Identifier Type: -
Identifier Source: org_study_id