Clinical trial NCT06319820: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Muscle Invasive Bladder Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

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)

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)
Secondary outcomes:
measure: Time to next Treatment (TTNT)
timeFrame: From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)
measure: High Grade Recurrence-free Survival (HG RFS)
timeFrame: From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)
measure: Progression Free Survival (PFS)
timeFrame: From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)
measure: Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment
timeFrame: From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)
measure: Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)
timeFrame: From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death (approximately 4 years and 2 months)
measure: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores
timeFrame: Baseline, Weeks 6, 12, 24, 36, and 48
measure: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores
timeFrame: Baseline, Weeks 6, 12, 24, 36, and 48
measure: Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores
timeFrame: Weeks 6, 12, 24, 36, and 48
measure: Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores
timeFrame: Weeks 6, 12, 24, 36, and 48
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Los Alamitos
country: United States
facility: Genesis Research LLC
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: San Diego
country: United States
facility: Genesis Research
state: California
city: Sherman Oaks
country: United States
facility: Genesis Research LLC
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center Anschultz Cancer Pavilion
state: Colorado
city: Lakewood
country: United States
facility: Colorado Clinical Research
state: Colorado
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Jeffersonville
country: United States
facility: First Urology
state: Indiana
city: Wichita
country: United States
facility: Wichita Urology Group
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Royal Oak
country: United States
facility: Comprehensive Urology
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Research
state: Missouri
city: Saint Louis
country: United States
facility: Specialty Clinical Research of St Louis
state: Missouri
city: Omaha
country: United States
facility: The Urology Center, PC
state: Nebraska
city: New Brunswick
country: United States
facility: Cancer Institute Of New Jersey
state: New Jersey
city: New York
country: United States
facility: Integrated Medical Professionals
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of Ny
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Med Univ
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Lancaster
country: United States
facility: Keystone Urology Specialists
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Germantown
country: United States
facility: The Conrad Pearson Clinic
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Spokane
country: United States
facility: Spokane Urology
state: Washington
city: Caba
country: Argentina
facility: Investigaciones Clinico Moleculares (ICM)
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Sirio Libanes
city: Cordoba
country: Argentina
facility: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
city: Cordoba
country: Argentina
facility: Centro Urologico Profesor Bengio
city: Mar del Plata
country: Argentina
facility: Hospital Privado de la Comunidad
city: Rosario
country: Argentina
facility: Sanatorio de la Mujer
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
city: Salzburg
country: Austria
facility: Universitaetsklinikum Salzburg Landeskrankenhaus
city: Wien
country: Austria
facility: Medical University Vienna MUV
city: Aalst
country: Belgium
facility: Onze -Lieve-Vrouwziekenhuis
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg
city: Sint Niklaas
country: Belgium
facility: Vitaz
city: Yvoir
country: Belgium
facility: CHU UCL Namur - Site Godinne
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Campinas
country: Brazil
facility: Universidade Estadual De Campinas
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
city: Salvador
country: Brazil
facility: HBA SA Assitencia Medica e Hospitalar
city: Santo Andre
country: Brazil
facility: Fundacao do ABC Centro Universitario FMABC
city: Sao Paulo
country: Brazil
facility: Irmandade Da Santa Casa De Misericordia De Sao Paulo
city: Sao Paulo
country: Brazil
facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: Beijing
country: China
facility: Beijing Friendship Hospital Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changsha
country: China
facility: Hunan Cancer hospital
city: Cheng Du Shi
country: China
facility: The Third People's Hospital of Chengdu
city: Cheng Du Shi
country: China
facility: West China School of Medicine/West China Hospital, Sichuan University
city: Chong Qing
country: China
facility: Chongqing Cancer Hospital
city: Fu Zhou Shi
country: China
facility: Fujian Medical University Union Hospital
city: Guang Zhou Shi
country: China
facility: Sun Yat Sen University Cancer Center
city: Nan Jing Shi
country: China
facility: Nanjing Drum Tower Hospital
city: Nan Jing Shi
country: China
facility: Zhongda Hospital Southeast University
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Tianjin
country: China
facility: The Second Hospital Of Tianjin Medical University
city: Urumqi
country: China
facility: Cancer Hospital of Xinjiang Medical University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wu Han Shi
country: China
facility: Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
city: XI An Shi
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Kobenhavn
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Lille
country: France
facility: Hospital Center University De Lille
city: Limoges
country: France
facility: Polyclinique de Limoges - Francois Chenieux
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: CHU Pitie Salpetriere
city: Paris
country: France
facility: APHP - Hopital Bichat - Claude Bernard
city: Quint-Fonsegrives
country: France
facility: Clinique de la Croix du Sud
city: Rennes
country: France
facility: Chu Rennes Hopital Pontchaillou
city: Toulouse
country: France
facility: CHU Rangueil
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin (CCM)
city: Braunschweig
country: Germany
facility: Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
city: Dresden
country: Germany
facility: Urologische Gemeinschaftspraxis
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Urologikum Hamburg MVZ - Germany
city: Herne
country: Germany
facility: Marien hospital Herne
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Koeln
country: Germany
facility: Studienzentrum Bayenthal
city: Munchen
country: Germany
facility: Klinikum rechts der Isar an der Technischen Universitat Munchen
city: Straubing
country: Germany
facility: Klinikum St. Elisabeth Straubing GmbH
city: Stuttgart
country: Germany
facility: Katharinenhospital Innere Medizin
city: Hong Kong
country: Hong Kong
facility: Prince Of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Dublin
country: Ireland
facility: Adelaide and Meath Hospital
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah University Hospita Ein Kerem
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Safed
country: Israel
facility: Ziv Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Arezzo
country: Italy
facility: Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica
city: Bergamo
country: Italy
facility: Cliniche Humanitas Gavazzeni
city: Brescia
country: Italy
facility: ASST Spedali Civili Brescia
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Istituto Dei Tumori Di Milano
city: Roma
country: Italy
facility: Universita Campus Bio-Medico di Roma
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: A.O.Citta della Salute e della Scienza di Torino
city: Amagasaki shi
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
city: Kawasaki Shi
country: Japan
facility: St Marianna University Hospital
city: Kobe City
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kumamoto City
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center
city: Saitama
country: Japan
facility: Saitama Medical Center
city: Wakayama
country: Japan
facility: JRC Wakayama Medical Center
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizen's Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
city: Chungcheongbuk Do
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Bydgoszcz
country: Poland
facility: IN VIVO Sp. z o.o
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 4
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
city: Tarnow
country: Poland
facility: Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
city: Torun
country: Poland
facility: Medicover Integrated Clinical Services Sp z o o
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny Sp z o o
city: Wroclaw
country: Poland
facility: 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Alzira
country: Spain
facility: Hosp. Univ. de La Ribera
city: Barcelona
country: Spain
facility: Fund. Puigvert
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Cadiz
country: Spain
facility: Hosp. Puerta Del Mar
city: Castellon
country: Spain
facility: Hosp. Gral. Univ. de Castellon
city: Jerez De La Frontera
country: Spain
facility: Hosp. de Jerez de La Frontera
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Clinica Univ. de Navarra
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Malaga
country: Spain
facility: Hosp Virgen de La Victoria
city: Oviedo
country: Spain
facility: Hosp. Univ. Central de Asturias
city: Sabadell
country: Spain
facility: Hosp.Univ.Parc Tauli
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Adana
country: Turkey
facility: Adana Baskent Practice and Research Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Kartal Dr Lutfi Kirdar sehir Hastanesi
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: London
country: United Kingdom
facility: St Bartholomews Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Freeman Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Johnson & Johnson Enterprise Innovation Inc.
name: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial
role: STUDY_DIRECTOR
References: