A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (MoonRISe-1)

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Muscle Invasive Bladder Neoplasms
• Intervention / Treatment: Combination product: TAR-210; Drug: Gemcitabine; Drug: MMC

• Study Type: Interventional
• Enrollment (Estimated): 641
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1419AHN
    • Active, not recruiting
    • Hospital Sirio Libanês
  • CABA, Argentina, C1425
    • Active, not recruiting
    • Investigaciones Clinico Moleculares (ICM)
  • Córdoba, Argentina, 5000
    • Active, not recruiting
    • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Córdoba, Argentina, X5000KPH
    • Active, not recruiting
    • Centro Urologico Profesor Bengio
  • Mar del Plata, Argentina, B7602
    • Active, not recruiting
    • Hospital Privado de La Comunidad
  • Rosario, Argentina, 2000
    • Active, not recruiting
    • Sanatorio de la Mujer
• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medizinische Universitaet Graz
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medizinische Universitat Innsbruck
  • Linz, Austria, 4020
    • Recruiting
    • Ordensklinikum Linz GmbH Elisabethinen
  • Salzburg, Austria, 5020
    • Recruiting
    • Universitaetsklinikum Salzburg Landeskrankenhaus
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University Vienna MUV
• Belgium
  • Aalst, Belgium, 9300
    • Recruiting
    • AZORG campus Aalst Moorselbaan
  • Bruges, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan
  • Edegem, Belgium, 2650
    • Completed
    • UZ Antwerpen
  • Ghent, Belgium, 9000
    • Recruiting
    • AZ Maria Middelares
  • Leuven, Belgium, 3000
    • Active, not recruiting
    • Universitair Ziekenhuis Gasthuisberg
  • Sint-Niklaas, Belgium, 9100
    • Recruiting
    • VITAZ
  • Yvoir, Belgium, 5530
    • Recruiting
    • CHU UCL Namur - Site Godinne
• Brazil
  • Barretos, Brazil, 14780-070
    • Active, not recruiting
    • Fundação Pio XII
  • Campinas, Brazil, 13083-888
    • Completed
    • Universidade Estadual de Campinas
  • Natal, Brazil, 59062 000
    • Active, not recruiting
    • Liga Norte Riograndense Contra o Câncer
  • Porto Alegre, Brazil, 90035-001
    • Active, not recruiting
    • Associacao Hospitalar Moinhos de Vento
  • Porto Alegre, Brazil, 90050170
    • Active, not recruiting
    • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Salvador, Brazil, 41810-011
    • Active, not recruiting
    • HBA SA Assitencia Medica e Hospitalar
  • Santo André, Brazil, 09060 870
    • Active, not recruiting
    • Fundacao do ABC Centro Universitario FMABC
  • São Paulo, Brazil, 01323 900
    • Active, not recruiting
    • Real e Benemérita Associação Portuguesa de Beneficência
  • São Paulo, Brazil, 01221-020
    • Active, not recruiting
    • Irmandade Da Santa Casa De Misericordia De Sao Paulo
  • São Paulo, Brazil, 01246-000
    • Active, not recruiting
    • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
  • São Paulo, Brazil, 01509 900
    • Completed
    • Fundacao Antonio Prudente A C Camargo Cancer Center
• China
  • Beijing, China, 100191
    • Active, not recruiting
    • Peking University Third Hospital
  • Beijing, China, 100050
    • Active, not recruiting
    • Beijing Friendship Hospital Capital Medical University
  • Changsha, China, 410013
    • Active, not recruiting
    • Hunan Cancer Hospital
  • Cheng Du Shi, China, 610014
    • Active, not recruiting
    • The Third People's Hospital of Chengdu
  • Cheng Du Shi, China, 610041
    • Active, not recruiting
    • West China School of Medicine/West China Hospital, Sichuan University
  • Chongqing, China, 400033
    • Active, not recruiting
    • Chongqing Cancer Hospital
  • Fuzhou, China, 350001
    • Active, not recruiting
    • Fujian Medical University Union Hospital
  • Guangzhou, China, 510060
    • Active, not recruiting
    • Sun Yat Sen University Cancer Center
  • Nanjing, China, 210008
    • Active, not recruiting
    • Nanjing Drum Tower Hospital
  • Nanjing, China, 210009
    • Active, not recruiting
    • Zhongda Hospital Southeast University
  • Shanghai, China, 200031
    • Active, not recruiting
    • Huadong Hospital Affiliated to Fudan University
  • Tianjin, China, 300061
    • Active, not recruiting
    • The Second Hospital of Tianjin Medical University
  • Wenzhou, China, 325000
    • Active, not recruiting
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430032
    • Active, not recruiting
    • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Xi'an, China, 710063
    • Active, not recruiting
    • The First Affiliated Hospital of Xian Jiaotong University
  • Xuzhou, China, 221004
    • Active, not recruiting
    • The Affiliated Hospital of Xuzhou Medical University
  • Ürümqi, China, 830011
    • Active, not recruiting
    • Cancer Hospital of Xinjiang Medical University
• Czechia
  • Hradec Králové, Czechia, 500 05
    • Completed
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czechia, 779 00
    • Recruiting
    • Fakultni Nemocnice Olomouc
  • Prague, Czechia, 128 08
    • Recruiting
    • Vseobecna fakultni nemocnice v Praze
  • Prague, Czechia, 150 06
    • Recruiting
    • Fakultni nemocnice v Motole
  • Prague, Czechia, 140 59
    • Recruiting
    • Fakultni Thomayerova nemocnice
• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev Hospital
  • Odense, Denmark, 5000
    • Recruiting
    • Odense Universitetshospital
  • Roskilde, Denmark, 4000
    • Recruiting
    • Zealand University Hospital
• France
  • Lille, France, 59000
    • Completed
    • Hospital Center University De Lille
  • Limoges, France, 87000
    • Recruiting
    • Polyclinique de Limoges - Francois Chenieux
  • Lyon, France, 69003
    • Recruiting
    • Hôpital Edouard Herriot
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli Calmettes
  • Paris, France, 75010
    • Recruiting
    • Hopital Saint Louis
  • Paris, France, 75013
    • Recruiting
    • CHU Pitie Salpetriere
  • Paris, France, 75018
    • Recruiting
    • APHP - Hopital Bichat - Claude Bernard
  • Quint-Fonsegrives, France, 31130
    • Recruiting
    • Clinique de la Croix du Sud
  • Rennes, France, 35000
    • Completed
    • Chu Rennes Hopital Pontchaillou
  • Toulouse, France, 31059
    • Recruiting
    • CHU Rangueil
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
• Germany
  • Berlin, Germany, 10117
    • Active, not recruiting
    • Charite - Universitaetsmedizin Berlin (CCM)
  • Braunschweig, Germany, 38126
    • Recruiting
    • Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
  • Cologne, Germany, 50968
    • Recruiting
    • Studienzentrum Bayenthal
  • Dresden, Germany, 01307
    • Completed
    • Urologische Gemeinschaftspraxis
  • Frankfurt am Main, Germany, 60596
    • Recruiting
    • Universitaetsklinikum Frankfurt
  • Hamburg, Germany, 22081
    • Active, not recruiting
    • Urologikum Hamburg MVZ - Germany
  • Herne, Germany, 44625
    • Recruiting
    • Marien Hospital Herne
  • Jena, Germany, 07747
    • Active, not recruiting
    • Universitatsklinikum Jena
  • München, Germany, 81675
    • Completed
    • Klinikum rechts der Isar an der Technischen Universitat Munchen
  • Straubing, Germany, 94315
    • Recruiting
    • Klinikum St. Elisabeth Straubing GmbH
  • Stuttgart, Germany, 70174
    • Completed
    • Katharinenhospital Innere Medizin
• Hong Kong
  • Hong Kong, Hong Kong
    • Active, not recruiting
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Active, not recruiting
    • Prince of Wales Hospital
• Ireland
  • Cork, Ireland, T12 DC4A
    • Active, not recruiting
    • Cork University Hospital
  • Dublin, Ireland, D07 A8NN
    • Active, not recruiting
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, D07 WKW8
    • Active, not recruiting
    • Mater Private Hospital
  • Dublin, Ireland, D24 NR0A
    • Active, not recruiting
    • Adelaide and Meath Hospital
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9112001
    • Completed
    • Hadassah University Hospita Ein Kerem
  • Ramat Gan, Israel, 5262000
    • Recruiting
    • Sheba Medical Center
  • Safed, Israel, 13100
    • Recruiting
    • Ziv Medical Center
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Sourasky Medical Center
• Italy
  • Arezzo, Italy, 52100
    • Recruiting
    • Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica
  • Bergamo, Italy, 24125
    • Recruiting
    • Cliniche Humanitas Gavazzeni
  • Brescia, Italy, 25123
    • Recruiting
    • ASST Spedali Civili Brescia
  • Milan, Italy, 20133
    • Recruiting
    • Istituto Dei Tumori Di Milano
  • Milan, Italy, 20132
    • Completed
    • Ospedale San Raffaele
  • Roma, Italy, 00144
    • Recruiting
    • Istituto Nazionale Tumori Regina Elena
  • Roma, Italy, 00128
    • Recruiting
    • Università Campus Bio-Medico di Roma
  • Rozzano, Italy, 20089
    • Recruiting
    • Istituto Clinico Humanitas
  • Torino, Italy, 10126
    • Recruiting
    • A.O.Citta della Salute e della Scienza di Torino
• Japan
  • Amagasaki Shi, Japan, 660 8550
    • Active, not recruiting
    • Hyogo Prefectural Amagasaki General Medical Center
  • Kawasaki Shi, Japan, 216 8511
    • Recruiting
    • St Marianna University Hospital
  • Kobe, Japan, 650 0047
    • Active, not recruiting
    • Kobe City Medical Center General Hospital
  • Kumamoto, Japan, 860 0008
    • Active, not recruiting
    • National Hospital Organization Kumamoto Medical Center
  • Osaka, Japan, 541 8567
    • Recruiting
    • Osaka International Cancer Institute
  • Saitama, Japan, 350 8550
    • Active, not recruiting
    • Saitama Medical Center
  • Wakayama, Japan, 640 8558
    • Active, not recruiting
    • JRC Wakayama Medical Center
  • Yokohama, Japan, 221 0855
    • Recruiting
    • Yokohama Municipal Citizen's Hospital
  • Yokohama, Japan, 232 0024
    • Active, not recruiting
    • Yokohama City University Medical Center
  • Yokosuka, Japan, 238 8558
    • Recruiting
    • Yokosuka Kyosai Hospital
  • Ōta-ku, Japan, 373 8550
    • Recruiting
    • Gunma Prefectural Cancer Center
• Poland
  • Bialystok, Poland, 15 276
    • Recruiting
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Bydgoszcz, Poland, 85 048
    • Recruiting
    • IN VIVO Sp. z o.o
  • Bydgoszcz, Poland, 85 796
    • Completed
    • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
  • Lublin, Poland, 20 090
    • Recruiting
    • Uniwersytecki Szpital Kliniczny nr 4
  • Przemyśl, Poland, 37 700
    • Active, not recruiting
    • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
  • Tarnów, Poland, 33-100
    • Recruiting
    • Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
  • Torun, Poland, 87-100
    • Completed
    • Medicover Integrated Clinical Services Sp z o o
  • Wieliszew, Poland, 05-135
    • Recruiting
    • Mazowiecki Szpital Onkologiczny Sp z o o
  • Wroclaw, Poland, 53-413
    • Recruiting
    • Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii
  • Wroclaw, Poland, 50 981
    • Completed
    • 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
• South Korea
  • Chungcheongbuk Do, South Korea, 28644
    • Completed
    • Chungbuk National University Hospital
  • Gyeonggi-do, South Korea, 10408
    • Recruiting
    • National Cancer Center
  • Jeollanam-do, South Korea, 58128
    • Recruiting
    • Chonnam National University Hwasun Hospital
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 3080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 06591
    • Active, not recruiting
    • The Catholic University of Korea Seoul St Marys Hospital
• Spain
  • A Coruña, Spain, 15006
    • Recruiting
    • Hosp Univ A Coruna
  • Alzira, Spain, 46600
    • Recruiting
    • Hosp. Univ. de La Ribera
  • Barcelona, Spain, 08025
    • Recruiting
    • Fund. Puigvert
  • Barcelona, Spain, 08036
    • Recruiting
    • Hosp Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Completed
    • Hosp Univ Vall D Hebron
  • Cadiz, Spain, 11009
    • Recruiting
    • Hosp. Puerta Del Mar
  • Castellon, Spain, 12004
    • Recruiting
    • Hosp. Gral. Univ. de Castellon
  • Jerez de la Frontera, Spain, 11407
    • Recruiting
    • Hosp. de Jerez de La Frontera
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28027
    • Recruiting
    • Clinica Univ. de Navarra
  • Madrid, Spain, 28007
    • Completed
    • Hosp. Gral. Univ. Gregorio Maranon
  • Málaga, Spain, 29010
    • Recruiting
    • Hosp Virgen de La Victoria
  • Oviedo, Spain, 33011
    • Completed
    • Hosp. Univ. Central de Asturias
  • Sabadell, Spain, 08208
    • Recruiting
    • Hosp.Univ.Parc Tauli
  • Seville, Spain, 41013
    • Completed
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46010
    • Recruiting
    • Hosp. Clinico Univ. de Valencia
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01120
    • Completed
    • Adana Baskent Practice and Research Hospital
  • Ankara, Turkey (Türkiye), 06200
    • Recruiting
    • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06100
    • Completed
    • Ankara University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34722
    • Recruiting
    • T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34865
    • Recruiting
    • Kartal Dr Lutfi Kirdar Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34153
    • Completed
    • Istanbul University Cerrahpasa Medical Faculty
  • Izmir, Turkey (Türkiye), 35330
    • Recruiting
    • Dokuz Eylul University Medical Faculty
• United Kingdom
  • Bristol, United Kingdom, BS105NB
    • Recruiting
    • Southmead Hospital
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • St Bartholomews Hospital
  • London, United Kingdom, W6 8RF
    • Recruiting
    • Charing Cross Hospital
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • Newcastle Freeman Hospital
  • Sheffield, United Kingdom, S10 2SJ
    • Recruiting
    • Sheffield Teaching Hospitals NHS Foundation Trust
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • Southampton General Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • Royal Marsden Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Completed
      • Arkansas Urology
  • California
    • Los Alamitos, California, United States, 90720
      • Active, not recruiting
      • Genesis Research LLC
    • Los Angeles, California, United States, 90033
      • Active, not recruiting
      • USC Norris Comprehensive Cancer Center
    • Orange, California, United States, 92868
      • Active, not recruiting
      • University of California Irvine Medical Center
    • San Diego, California, United States, 92123
      • Active, not recruiting
      • Om Research LLC
    • Sherman Oaks, California, United States, 91411
      • Completed
      • Genesis Research LLC 1
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Completed
      • University of Colorado Cancer Center Anschultz Cancer Pavilion
    • Lakewood, Colorado, United States, 80228
      • Active, not recruiting
      • Colorado Clinical Research
  • Florida
    • Tampa, Florida, United States, 33612
      • Active, not recruiting
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Completed
      • Northwestern University
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • Completed
      • First Urology
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Active, not recruiting
      • Wichita Urology Group
  • Louisiana
    • New Orleans, Louisiana, United States, 70121-2429
      • Active, not recruiting
      • Ochsner Health System
  • Maryland
    • Hanover, Maryland, United States, 21076
      • Completed
      • Chesapeake Urology Research Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Completed
      • Brigham and Women's Hospital
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Active, not recruiting
      • Karmanos Cancer Institute
    • Royal Oak, Michigan, United States, 48073
      • Active, not recruiting
      • Comprehensive Urology
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Active, not recruiting
      • Specialty Clinical Research of St Louis
    • St Louis, Missouri, United States, 63141
      • Completed
      • Mercy Research
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Active, not recruiting
      • The Urology Center, PC
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Active, not recruiting
      • Cancer Institute Of New Jersey
  • New York
    • New York, New York, United States, 10065
      • Active, not recruiting
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10016
      • Completed
      • Integrated Medical Professionals
    • Syracuse, New York, United States, 13210
      • Active, not recruiting
      • Associated Medical Professionals of NY
    • Syracuse, New York, United States, 13210
      • Active, not recruiting
      • SUNY Upstate Med Univ
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Active, not recruiting
      • Levine Cancer Institute
    • Raleigh, North Carolina, United States, 27612
      • Active, not recruiting
      • Associated Urologists of North Carolina
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Active, not recruiting
      • MidLantic Urology
    • Lancaster, Pennsylvania, United States, 17604
      • Active, not recruiting
      • Keystone Urology Specialists
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Active, not recruiting
      • Carolina Urologic Research Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Active, not recruiting
      • The Conrad Pearson Clinic
    • Knoxville, Tennessee, United States, 37920
      • Completed
      • University of Tennessee Medical Center
    • Nashville, Tennessee, United States, 37209
      • Active, not recruiting
      • Urology Associates
  • Texas
    • Austin, Texas, United States, 78745
      • Active, not recruiting
      • Urology Austin
    • Dallas, Texas, United States, 75231
      • Active, not recruiting
      • Urology Clinics of North Texas
    • Dallas, Texas, United States, 75390
      • Completed
      • UT Southwestern
    • Houston, Texas, United States, 77027
      • Active, not recruiting
      • Houston Metro Urology
  • Washington
    • Spokane, Washington, United States, 99202
      • Active, not recruiting
      • Spokane Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Main study only: 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)
• Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and >=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor >=3 cm
• 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:

• 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)

Substudy:

- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main Study: 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.	Combination product: TAR-210; TAR-210 will be administered intravesically.; Other Names: JNJ-42756493
Active Comparator: Main Study: 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.	Drug: Gemcitabine; Gemcitabine will be administered intravesically.; Drug: MMC; MMC will be administered intravesically.
Experimental: Substudy: 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.	Combination product: TAR-210; TAR-210 will be administered intravesically.; Other Names: JNJ-42756493
Active Comparator: Substudy: Group B: MMC; Participants in substudy Group B will receive intravesical MMC once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.	Drug: MMC; MMC will be administered intravesically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival (DFS)	DFS is measured as the time from randomization to the date of the first documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.	From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to next Treatment (TTNT)	TTNT is measured as the time from randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer.	From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)
High Grade Recurrence-free Survival (HG RFS)	HG RFS is measured as the time from randomization to the date of first documented evidence of HG NMIBC or death, whichever occurs first	From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)
Progression Free Survival (PFS)	PFS is measured as the time from randomization to the date of first documented evidence of disease progression or death, whichever occurs first.	From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)
Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)	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.	From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)
Overall Survival (OS)	OS is defined as the time from randomization to the date of death from any cause.	From randomization to the date of death (approximately 4 years and 2 months)
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores	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.	Baseline, Weeks 6, 12, 24, 36, and 48
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores	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.	Baseline, Weeks 6, 12, 24, 36, and 48
Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores	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.	Weeks 6, 12, 24, 36, and 48
Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores	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.	Weeks 6, 12, 24, 36, and 48
Number of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment	Number 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.	From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Estimated): June 28, 2028
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; erdafitinib
• Other Study ID Numbers: 42756493BLC3004 (Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No