Bladder Cancer Clinical Trial

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

Summary

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

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Full Description

Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG. The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total duration of the study will be up to 5 years and 2 months. Efficacy, Safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve
BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)
All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma [HGUC]) for patients with papillary only disease (without CIS)
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to date of randomization
Participants must be willing to undergo all study procedures

Exclusion Criteria:

Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to [>=] T2)
Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization
Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded
A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL)
Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

1050

Study ID:

NCT05714202

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 235 Locations for this study

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Mayo Clinic
Scottsdale Arizona, 85259, United States
Arkansas Urology
Little Rock Arkansas, 72211, United States
VA Long Beach Health Care System
Long Beach California, 90822, United States
Genesis Research, LLC - West Coast Urology
Los Alamitos California, 90720, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95630, United States
Genesis Research
San Diego California, 92123, United States
Providence Saint Johns Cancer Institute
Santa Monica California, 90404, United States
Providence Medical Foundation
Santa Rosa California, 95403, United States
Colorado Clinical Research
Lakewood Colorado, 80228, United States
Urological Research Network
Hialeah Florida, 33016, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Sarasota Memorial Hospital
Sarasota Florida, 34239, United States
Grady Memorial Hospital
Atlanta Georgia, 30303, United States
The Emory Clinic Department of Urology
Atlanta Georgia, 30322, United States
Northwestern University
Chicago Illinois, 60611, United States
Duly Health and Care
Lisle Illinois, 60532, United States
Blessing Hospital
Quincy Illinois, 62301, United States
Urology of Indiana
Carmel Indiana, 46032, United States
First Urology
Jeffersonville Indiana, 47130, United States
AMR Kansas City Oncology
Merriam Kansas, 66204, United States
Wichita Urology Group
Wichita Kansas, 67226, United States
Chesapeake Urology Research Associates
Hanover Maryland, 21076, United States
Lahey Hospital & Medical Center
Burlington Massachusetts, 01805, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
University Of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
The Urology Center, PC
Omaha Nebraska, 68114, United States
Cooper Health System MD Anderson Cancer Center at Cooper
Camden New Jersey, 08103, United States
VA NY Harbor Healthcare System
New York New York, 10010, United States
Icahn School of Medicine at Mt. Sinai
New York New York, 10029, United States
Associated Medical Professionals of Ny
Syracuse New York, 13210, United States
SUNY Upstate Med Univ
Syracuse New York, 13210, United States
Vidant Urology - Greenville
Greenville North Carolina, 27834, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Central Ohio Urology Group
Gahanna Ohio, 43230, United States
Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
UPMC Shadyside Hospital
Pittsburgh Pennsylvania, 15232, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Urology Associates
Nashville Tennessee, 37209, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Urology Austin
Austin Texas, 78745, United States
Urology Clinics of North Texas
Dallas Texas, 75231, United States
Houston Metro Urology
Houston Texas, 77027, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
Urology San Antonio Research
San Antonio Texas, 78229, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
George E. Wahlen VAMC
Salt Lake City Utah, 84148, United States
Urology Of Virginia, Pllc
Virginia Beach Virginia, 23462, United States
Spokane Urology
Spokane Washington, 99202, United States
Hospital Italiano de Buenos Aires
Buenos Aires , C1199, Argentina
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
Buenos Aires , C1417, Argentina
Centro Urologico Profesor Bengio
Cordoba , X5000, Argentina
Hospital Privado - Centro Medico de Cordoba
Cordoba , X5016, Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba , 5000, Argentina
Hospital Privado de la Comunidad
Mar del Plata , B7602, Argentina
Instituto Medico Rio Cuarto
Rio Cuarto , 5800, Argentina
Austin Health
Heidelberg , 3084, Australia
Macquarie University Hospital
Macquarie University , 2109, Australia
Hollywood Private Hospital
Nedlands , 6009, Australia
Mater Hospital Brisbane
South Brisbane , 4101, Australia
ZNA Middelheim
Antwerpen , 2020, Belgium
AZ Sint-Jan
Brugge , 8000, Belgium
AZ Sint-Lucas
Brugge , 8310, Belgium
AZ Maria Middelares
Gent , 9000, Belgium
UZ Gent
Gent , 9000, Belgium
Centre Hospitalier de l'Ardenne
Libramont-Chevigny , 6800, Belgium
AZ Delta
Roeselare , 8800, Belgium
Vitaz
Sint-Niklaas , 9100, Belgium
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk , 2610, Belgium
Fundacao Pio XII
Barretos , 14784, Brazil
NAIC Nair Antunes Instituto do Cancer
Bauru , 17033, Brazil
Universidade Estadual De Campinas
Campinas , 13083, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba , 81520, Brazil
Liga Norte Riograndense Contra O Cancer
Natal , 59075, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90050, Brazil
Hospital Regional do Cancer - Hospital de Esperança
Presidente Prudente , 19013, Brazil
Hospital Sao Rafael
Salvador , 41253, Brazil
Hospital Ana Nery Santa Cruz do Sul
Santa Cruz Do Sul , 96835, Brazil
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo Andre , 09060, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
Sao Paulo , 01246, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
Sao Paulo , 1321-, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo , 01508, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo , 05652, Brazil
Nova Scotia Health Authority
Halifax Nova Scotia, B3H 2, Canada
St Josephs Healthcare Hamilton
Hamilton Ontario, L8N 4, Canada
Princess Margaret Cancer Centre University Health Network
Toronto Ontario, M5G 1, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montréal Quebec, H2X 3, Canada
Unite de Recherche Clinique du CISSS des Laurentides
Saint Jerome Quebec Quebec, J7Z 2, Canada
CHU de Quebec Universite Laval Hopital de l Enfant Jesus
Quebec , G1J1Z, Canada
Peking University First Hospital
Beijing , 10003, China
Beijing Hospital
Beijing , 10073, China
Beijing Luhe Hospital, Capital Medical University
Beijing , 10110, China
Hunan Province Cancer Hospital
Chang Sha , 41001, China
The First Bethune Hospital of Jilin University
Changchun , 13049, China
West China Hospital Sichuan University
Chengdu , 61004, China
Chongqing University Cancer Hospital
Chongqing , 40000, China
People's Hospital of Deyang City
Deyang City , 61800, China
Sun Yat-Sen University Cancer Center
GuangZhou , 43003, China
Zhejiang Provincial People's Hospital
Hangzhou , 31000, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou , 31001, China
Nanjing Drum Tower Hospital
Nanjing , 21000, China
The First Affiliated Hospital of Ningbo University
Ningbo , 31501, China
Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
Shanghai , 20002, China
Huadong Hospital Affiliated to Fudan University
Shanghai , 20040, China
Shengjing Hospital of China Medical University
Shenyang , 11000, China
The Second Hospital of Tianjin Medical University
Tianjin , 30021, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , 32500, China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan , 43003, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xian , 71006, China
Yantai Yuhuangding Hospital
Yantai , 26400, China
Henan Cancer Hospital
Zhengzhou , 45000, China
Fakultni nemocnice u sv. Anny v Brne
Brno , 65691, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové , 500 0, Czechia
Krajská nemocnice Liberec a.s.
Liberec , 460 0, Czechia
Fakultní nemocnice Olomouc
Olomouc , 779 0, Czechia
Fakultni nemocnice v Motole
Prague , 15006, Czechia
Thomayerova nemocnice, Onkologicka klinika
Praha 4 , 140 5, Czechia
Fakultni nemocnice Kralovske Vinohrady
Praha , 100 3, Czechia
Polyclinique Bordeaux Nord Acquitaine
Bordeaux , 33000, France
CHU Gabriel-Montpied
Clermont-Ferrand , 63003, France
CHU Grenoble
Grenoble , 38043, France
Polyclinique de Limoges - Francois Chenieux
Limoges , 87000, France
Hôpital Edouard Herriot
Lyon , 69437, France
CHU de Nantes hotel Dieu
Nantes , 44093, France
CHU Nîmes
Nimes , 30029, France
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
Orléans , 45067, France
Groupe Hospitalier Diaconesses Croix Saint Simon
PARIS cedex 20 , 75960, France
Hôpital Universitaire Pitié-Salpêtrière
Paris , 75013, France
Hopital Europeen Georges-Pompidou
Paris , 75015, France
APHP - Hopital Bichat - Claude Bernard
Paris , 75018, France
Clinical La Croix Du Sud - Ramsay Santé
Quint-Fonsegrives , 31130, France
Chu Rennes Hopital Pontchaillou
Rennes , 35000, France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg , 67200, France
CHU Rangueil
Toulouse , 31059, France
Urologicum Duisburg
Duisburg , 47169, Germany
Universitatsklinikum Erlangen
Erlangen , 91054, Germany
Universitatsklinikum Essen
Essen , 45147, Germany
Universitaetsklinikum Frankfurt
Frankfurt am Main , 60590, Germany
Universitaetsklinikum Freiburg
Freiburg , 79106, Germany
Urologische Partnerschaft Koln UPK
Köln , 50968, Germany
Matthias Schulze - Germany
Markkleeberg , 04416, Germany
Urologie Neandertal Praxis Mettmann
Mettmann , 40822, Germany
Universitatsklinikum Munster
Muenster , 48149, Germany
Klinikum rechts der Isar an der Technischen Universitat Munchen
München , 81675, Germany
Klinikum Nurnberg Nord
Nuernberg , 90419, Germany
Medizinisches Versorgungszentrum - Urologie
Nurnberg , 90491, Germany
Studienpraxis Urologie Nurtingen
Nürtingen , 72622, Germany
Caritas-Krankenhaus St. Josef
Regensburg , 93053, Germany
Universitat Tubingen
Tübingen , 72076, Germany
Health Care Global Enterprises pvt Ltd
Bangalore , 56002, India
Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh , 16001, India
Artemis Hospital
Gurugram , 12200, India
Netaji Subhas chandra Bose Cancer Research Institute
Kolkata , 70009, India
Tata Memorial Hospital
Mumbai , 40001, India
CIMET s Inamdar Multispeciality Hospital
Pune , 41104, India
Generale Regionale F. Miulli
Acquaviva delle Fonti , 70021, Italy
Ospedale Cardinal Massaia
Asti , 14100, Italy
Ospedale San Giuseppe Moscati di Avellino
Avellino , 83100, Italy
Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale
Castelfranco Veneto , 31033, Italy
Ospedale San Raffaele di Milano
Milano , 20132, Italy
Istituto Europeo di Oncologia
Milano , 20141, Italy
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Napoli , 80138, Italy
Ospedale S. Maria Delle Croci
Ravenna , 48121, Italy
Istituto Nazionale Tumori Regina Elena
Rome , 00128, Italy
Fuji City General Hospital
Fuji-shi , 417-8, Japan
Kanazawa University Hospital
Kanazawa , 920-8, Japan
Nara Medical University Hospital
Kashihara-shi , 634-8, Japan
Kimitsu Chuo Hospital
Kisarazu-shi , 292-8, Japan
Kobe City Medical Center General Hospital
Kobe City , 650 0, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto-shi , 860-0, Japan
Nagano Municipal Hospital
Nagano-shi , 381-8, Japan
Nagasaki University Hospital
Nagasaki-shi , 852-8, Japan
JRC Nagasaki Genbaku Hospital
Nagasaki-Shi , 852-8, Japan
Saiseikai Narashino Hospital
Narashino-shi , 275-8, Japan
Ehime University Hospital
Toon-shi , 791-0, Japan
Toyama University Hospital
Toyama-shi , 930-0, Japan
Yamaguchi University Hospital
Ube , 755-8, Japan
Yokohama City University Medical Center
Yokohama , 232 0, Japan
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Chungbuk National University Hospital
Cheongju , 28644, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
Keimyung University Dongsan Hospital
Daegu , 42601, Korea, Republic of
National Cancer Center
Gyeonggi-do , 10408, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Kangbuk Samsung Hospital
Seoul , 03181, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Consultorio Medico dentro del Hospital Angeles Acoxpa
Ciudad de México , 14308, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey , 64460, Mexico
Avix Investigacion Clinica S C
Monterrey , 64710, Mexico
Eme Red Hospitalaria
Mérida , 97000, Mexico
Oncologico Potosino
San Luis Potosí , 78260, Mexico
Spaarne Ziekenhuis
Hoofddorp , 2134 , Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen , 6524 , Netherlands
Radboud Umcn
Nijmegen , 6525 , Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok , 15-27, Poland
IN VIVO Sp. z o.o
Bydgoszcz , 85-04, Poland
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
Lublin , 20-70, Poland
Centrum Medyczne
Piotrkow Trybunalski , 97-30, Poland
Clinical Research Center sp z o o MEDIC R s k
Poznan , 61 73, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,
Slupsk , 76-20, Poland
Provita Poliklinika
Warszawa , 02-64, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw , 50-55, Poland
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
Coimbra , 3000-, Portugal
Centro Hospitalar de Lisboa Norte Hospital Santa Maria
Lisboa , 1649 , Portugal
Centro Hospitalar de Vila Nova de Gaia Espinho E P E
Vila Nova de Gaia , 4434 , Portugal
Hosp. Univ. A Coruna
A Coruña , 15006, Spain
Hosp. Punta de Europa
Algeciras , 11207, Spain
Fund. Puigvert
Barcelona , 08025, Spain
Hosp. Gral. Univ. de Castellon
Castellon , 12004, Spain
Hosp. Puerta Del Mar
Cádiz , 11009, Spain
Hosp. Univ. de Bellvitge
L'Hospitalet de Llobregat , 08907, Spain
Hosp. Univ. Lucus Augusti
Lugo , 27003, Spain
Clinica Univ. de Navarra
Madrid , 28027, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. La Paz
Madrid , 28046, Spain
Hosp. Virgen de La Victoria
Málaga , 29010, Spain
Hosp. Univ. Marques de Valdecilla
Santander , 39008, Spain
Hosp. Clinico Univ. de Valencia
Valencia , 46010, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City , 807, Taiwan
Chang Kung Memorial Hospital
Kaohsiung , 833, Taiwan
China Medical University Hospital
Taichung City , 404, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan , 33382, Taiwan
Western General Hospital
Edinburgh , EH4 2, United Kingdom
St Bartholomews Hospital
London , EC1A , United Kingdom
The Royal Marsden NHS Trust
London , SW3 6, United Kingdom
Charing Cross Hospital
London , W6 8R, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Scunthorpe General Hospital
Scunthorpe , DN15 , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield , S10 2, United Kingdom
Lister Hospital
Stevenage , SG1 4, United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

1050

Study ID:

NCT05714202

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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