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NCT06319820PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

4/18/2024

Completion Date

12/31/2032

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

Age Range: 18 years to No maximum

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

Interventions

COMBINATION_PRODUCT

TAR-210

DRUG

Gemcitabine

DRUG

MMC

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Conditions

Non-Muscle Invasive Bladder Neoplasms

Locations

Arkansas Urology

Little Rock, Arkansas 72211

United States

Genesis Research LLC

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

Om Research LLC

San Diego, California 92123

United States

Genesis Research LLC 1

Sherman Oaks, California 91411

United States

University of Colorado Cancer Center Anschultz Cancer Pavilion

Aurora, Colorado 80045

United States

Colorado Clinical Research

Lakewood, Colorado 80228

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Northwestern University

Chicago, Illinois 60611

United States

First Urology

Jeffersonville, Indiana 47130

United States

Wichita Urology Group

Wichita, Kansas 67226

United States

Ochsner Health System

New Orleans, Louisiana 70121-2429

United States

Chesapeake Urology Research Associates

Hanover, Maryland 21076

United States

Brigham And Women's Hospital

Boston, Massachusetts 02115

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Comprehensive Urology

Royal Oak, Michigan 48073

United States

Mercy Research

St Louis, Missouri 63141

United States

Specialty Clinical Research of St Louis

St Louis, Missouri 63141

United States

The Urology Center, PC

Omaha, Nebraska 68114

United States

Cancer Institute Of New Jersey

New Brunswick, New Jersey 08901

United States

Integrated Medical Professionals

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Associated Medical Professionals of Ny

Syracuse, New York 13210

United States

SUNY Upstate Med Univ

Syracuse, New York 13210

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Associated Urologists of North Carolina

Raleigh, North Carolina 27612

United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania 19004

United States

Keystone Urology Specialists

Lancaster, Pennsylvania 17604

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina 29572

United States

The Conrad Pearson Clinic

Germantown, Tennessee 38138

United States

University of Tennessee Medical Center

Knoxville, Tennessee 37920

United States

Urology Associates

Nashville, Tennessee 37209

United States

Urology Austin

Austin, Texas 78745

United States

Urology Clinics of North Texas

Dallas, Texas 75231

United States

UT Southwestern

Dallas, Texas 75390

United States

Houston Metro Urology

Houston, Texas 77027

United States

Spokane Urology

Spokane, Washington 99202

United States

Hospital Sirio Libanes

Buenos Aires, C1419AHN

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

Sanatorio de la Mujer

Rosario, 2000

Argentina

Medizinische Universitaet Graz

Graz, 8036

Austria

Medizinische Universitat Innsbruck

Innsbruck, 6020

Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, 4020

Austria

Universitaetsklinikum Salzburg Landeskrankenhaus

Salzburg, 5020

Austria

Medical University Vienna MUV

Vienna, 1090

Austria

AZORG campus Aalst Moorselbaan

Aalst, 9300

Belgium

AZ Sint-Jan

Bruges, 8000

Belgium

UZ Antwerpen

Edegem, 2650

Belgium

AZ Maria Middelares

Ghent, 9000

Belgium

Universitair Ziekenhuis Gasthuisberg

Leuven, 3000

Belgium

Vitaz

Sint-Niklaas, 9100

Belgium

CHU UCL Namur - Site Godinne

Yvoir, 5530

Belgium

Fundacao Pio XII

Barretos, 14780-070

Brazil

Universidade Estadual De Campinas

Campinas, 13083-888

Brazil

Liga Norte Riograndense Contra O Cancer

Natal, 59062 000

Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, 90035-001

Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90050170

Brazil

HBA SA Assitencia Medica e Hospitalar

Salvador, 41810-011

Brazil

Fundacao do ABC Centro Universitario FMABC

Santo André, 09060 870

Brazil

Irmandade Da Santa Casa De Misericordia De Sao Paulo

São Paulo, 01221-020

Brazil

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246-000

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

Beijing Friendship Hospital Capital Medical University

Beijing, 100050

China

Peking University Third Hospital

Beijing, 100191

China

Hunan Cancer hospital

Changsha, 410013

China

The Third People's Hospital of Chengdu

Cheng Du Shi, 610014

China

West China School of Medicine/West China Hospital, Sichuan University

Cheng Du Shi, 610041

China

Chongqing Cancer Hospital

Chongqing, 400033

China

Fujian Medical University Union Hospital

Fuzhou, 350001

China

Sun Yat Sen University Cancer Center

Guangzhou, 510060

China

Nanjing Drum Tower Hospital

Nanjing, 210008

China

Zhongda Hospital Southeast University

Nanjing, 210009

China

Huadong Hospital Affiliated to Fudan University

Shanghai, 200031

China

The Second Hospital Of Tianjin Medical University

Tianjin, 300061

China

Cancer Hospital of Xinjiang Medical University

Ürümqi, 830011

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430032

China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710063

China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, 221004

China

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Fakultni nemocnice Olomouc

Olomouc, 779 00

Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 128 08

Czechia

Fakultni Thomayerova nemocnice

Prague, 140 59

Czechia

Fakultni nemocnice v Motole

Prague, 150 06

Czechia

Aarhus University Hospital

Aarhus, 8200

Denmark

Rigshospitalet

Copenhagen, 2100

Denmark

Herlev Hospital

Herlev, 2730

Denmark

Odense Universitetshospital

Odense, 5000

Denmark

Zealand University Hospital

Roskilde, 4000

Denmark

Hospital Center University De Lille

Lille, 59000

France

Polyclinique de Limoges - Francois Chenieux

Limoges, 87000

France

Hôpital Edouard Herriot

Lyon, 69003

France

Institut Paoli Calmettes

Marseille, 13009

France

Hopital Saint Louis

Paris, 75010

France

CHU Pitie Salpetriere

Paris, 75013

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

CHU Rangueil

Toulouse, 31059

France

Institut Gustave Roussy

Villejuif, 94805

France

Charite - Universitaetsmedizin Berlin (CCM)

Berlin, 10117

Germany

Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie

Braunschweig, 38126

Germany

Studienzentrum Bayenthal

Cologne, 50968

Germany

Urologische Gemeinschaftspraxis

Dresden, 01307

Germany

Universitaetsklinikum Frankfurt

Frankfurt am Main, 60596

Germany

Urologikum Hamburg MVZ - Germany

Hamburg, 22081

Germany

Marien hospital Herne

Herne, 44625

Germany

Universitatsklinikum Jena

Jena, 07747

Germany

Klinikum rechts der Isar an der Technischen Universitat Munchen

München, 81675

Germany

Klinikum St. Elisabeth Straubing GmbH

Straubing, 94315

Germany

Katharinenhospital Innere Medizin

Stuttgart, 70174

Germany

Prince Of Wales Hospital

Hong Kong,

Hong Kong

Queen Mary Hospital

Hong Kong,

Hong Kong

Cork University Hospital

Cork, T12 DC4A

Ireland

Mater Misericordiae University Hospital

Dublin, D07 A8NN

Ireland

Mater Private Hospital

Dublin, D07 WKW8

Ireland

Adelaide and Meath Hospital

Dublin, D24 NR0A

Ireland

Rambam Health Care Campus

Haifa, 3109601

Israel

Hadassah University Hospita Ein Kerem

Jerusalem, 9112001

Israel

Sheba Medical Center

Ramat Gan, 52621

Israel

Ziv Medical Center

Safed, 13100

Israel

Sourasky Medical Center

Tel Aviv, 6423906

Israel

Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica

Arezzo, 52100

Italy

Cliniche Humanitas Gavazzeni

Bergamo, 24125

Italy

ASST Spedali Civili Brescia

Brescia, 25123

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Istituto Dei Tumori Di Milano

Milan, 20133

Italy

Universita Campus Bio-Medico di Roma

Roma, 00128

Italy

Istituto Nazionale Tumori Regina Elena

Roma, 00144

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

A.O.Citta della Salute e della Scienza di Torino

Torino, 10126

Italy

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki Shi, 660 8550

Japan

St Marianna University Hospital

Kawasaki Shi, 216 8511

Japan

Kobe City Medical Center General Hospital

Kobe, 650 0047

Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, 860 0008

Japan

Osaka International Cancer Institute

Osaka, 541 8567

Japan

Gunma Prefectural Cancer Center

Ōta-ku, 373 8550

Japan

Saitama Medical Center

Saitama, 350 8550

Japan

JRC Wakayama Medical Center

Wakayama, 640 8558

Japan

Yokohama Municipal Citizen's Hospital

Yokohama, 221 0855

Japan

Yokohama City University Medical Center

Yokohama, 232 0024

Japan

Yokosuka Kyosai Hospital

Yokosuka, 238 8558

Japan

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15 276

Poland

IN VIVO Sp. z o.o

Bydgoszcz, 85 048

Poland

Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

Bydgoszcz, 85 796

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 Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie

Tarnów, 33-100

Poland

Medicover Integrated Clinical Services Sp z o o

Torun, 87-100

Poland

Mazowiecki Szpital Onkologiczny Sp z o o

Wieliszew, 05-135

Poland

4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu

Wroclaw, 50 981

Poland

Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii

Wroclaw, 53-413

Poland

Chungbuk National University Hospital

Chungcheongbuk Do, 28644

South Korea

National Cancer Center

Gyeonggi-do, 10408

South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591

South Korea

Seoul National University Hospital

Seoul, 3080

South Korea

Hosp Univ A Coruna

A Coruña, 15006

Spain

Hosp. Univ. de La Ribera

Alzira, 46600

Spain

Fund. Puigvert

Barcelona, 08025

Spain

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Hosp Clinic de Barcelona

Barcelona, 08036

Spain

Hosp. Puerta Del Mar

Cadiz, 11009

Spain

Hosp. Gral. Univ. de Castellon

Castellon, 12004

Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407

Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007

Spain

Clinica Univ. de Navarra

Madrid, 28027

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp Virgen de La Victoria

Málaga, 29010

Spain

Hosp. Univ. Central de Asturias

Oviedo, 33011

Spain

Hosp.Univ.Parc Tauli

Sabadell, 08208

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain

Hosp. Clinico Univ. de Valencia

Valencia, 46010

Spain

Adana Baskent Practice and Research Hospital

Adana, 01120

Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, 06100

Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, 06200

Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34153

Turkey (Türkiye)

T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

Istanbul, 34722

Turkey (Türkiye)

Kartal Dr Lutfi Kirdar sehir Hastanesi

Istanbul, 34865

Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, 35330

Turkey (Türkiye)

Southmead Hospital

Bristol, BS105NB

United Kingdom

St Bartholomews Hospital

London, EC1A 7BE

United Kingdom

Charing Cross Hospital

London, W6 8RF

United Kingdom

Newcastle Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2SJ

United Kingdom

Southampton General Hospital

Southampton, SO16 6YD

United Kingdom

Royal Marsden Hospital

Sutton, SM2 5PT

United Kingdom