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)

NCT ID: NCT05714202

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2029-09-18

Brief 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).

Detailed 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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group A: TAR-200 + Cetrelimab

Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.

Group Type: EXPERIMENTAL

TAR-200

Intervention Type: DRUG

TAR-200 will be administered intravesically.

Cetrelimab

Intervention Type: BIOLOGICAL

Cetrelimab will be administered.

Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture

Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).

Group Type: ACTIVE_COMPARATOR

BCG Vesiculture

Intervention Type: BIOLOGICAL

BCG will be administered intravesically.

Treatment Group C: TAR-200 Alone

Participants will receive intravesical TAR-200 alone once Q3W.

Group Type: EXPERIMENTAL

TAR-200

Intervention Type: DRUG

TAR-200 will be administered intravesically.

Interventions

TAR-200

TAR-200 will be administered intravesically.

Intervention Type: DRUG

Cetrelimab

Cetrelimab will be administered.

Intervention Type: BIOLOGICAL

BCG Vesiculture

BCG will be administered intravesically.

Intervention Type: BIOLOGICAL

Other Intervention Names

JNJ-17000139; JNJ-63723283

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Mayo Clinic

Scottsdale, Arizona, United States

Arkansas Urology

Little Rock, Arkansas, United States

VA Long Beach Health Care System

Long Beach, California, United States

Genesis Research, LLC - West Coast Urology

Los Alamitos, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Genesis Research

San Diego, California, United States

Providence Saint Johns Cancer Institute

Santa Monica, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Urological Research Network

Hialeah, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Grady Memorial Hospital

Atlanta, Georgia, United States

The Emory Clinic Department of Urology

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Duly Health and Care

Lisle, Illinois, United States

Blessing Hospital

Quincy, Illinois, United States

Urology of Indiana

Carmel, Indiana, United States

First Urology

Jeffersonville, Indiana, United States

AMR Kansas City Oncology

Merriam, Kansas, United States

Wichita Urology Group

Wichita, Kansas, United States

Chesapeake Urology Research Associates

Hanover, Maryland, United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

University Of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

The Urology Center, PC

Omaha, Nebraska, United States

Cooper Health System MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

VA NY Harbor Healthcare System

New York, New York, United States

Icahn School of Medicine at Mt. Sinai

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

Vidant Urology - Greenville

Greenville, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Central Ohio Urology Group

Gahanna, Ohio, United States

Centers for Advanced Urology LLC d b a MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Urology Associates

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Urology Austin

Austin, Texas, United States

Urology Clinics of North Texas

Dallas, Texas, United States

Houston Metro Urology

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Urology San Antonio Research

San Antonio, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

George E. Wahlen VAMC

Salt Lake City, Utah, United States

Urology Of Virginia, Pllc

Virginia Beach, Virginia, United States

Spokane Urology

Spokane, Washington, United States

Hospital Italiano de Buenos Aires

Buenos Aires, , Argentina

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

Buenos Aires, , Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, , Argentina

Centro Urologico Profesor Bengio

Córdoba, , Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, , Argentina

Hospital Privado de la Comunidad

Mar del Plata, , Argentina

Instituto Medico Rio Cuarto

Río Cuarto, , Argentina

Austin Health

Heidelberg, , Australia

Macquarie University Hospital

Macquarie University, , Australia

Hollywood Private Hospital

Nedlands, , Australia

Mater Hospital Brisbane

South Brisbane, , Australia

ZNA Middelheim

Antwerp, , Belgium

AZ Sint-Jan

Bruges, , Belgium

AZ Sint-Lucas

Bruges, , Belgium

AZ Maria Middelares

Ghent, , Belgium

UZ Gent

Ghent, , Belgium

Centre Hospitalier de l'Ardenne

Libramont-Chevigny, , Belgium

AZ Delta

Roeselare, , Belgium

Vitaz

Sint-Niklaas, , Belgium

GZA Ziekenhuizen- Campus St Augustinus

Wilrijk, , Belgium

Fundacao Pio XII

Barretos, , Brazil

NAIC Nair Antunes Instituto do Cancer

Bauru, , Brazil

Universidade Estadual De Campinas

Campinas, , Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, , Brazil

Liga Norte Riograndense Contra O Cancer

Natal, , Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Hospital Regional do Cancer - Hospital de Esperança

Presidente Prudente, , Brazil

Hospital Sao Rafael

Salvador, , Brazil

Hospital Ana Nery Santa Cruz do Sul

Santa Cruz do Sul, , Brazil

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, , Brazil

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

São Paulo, , Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, , Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, , Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, , Brazil

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

St Josephs Healthcare Hamilton

Hamilton, Ontario, Canada

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, Canada

CHUM - Centre hospitalier universitaire de Montreal

Montreal, Quebec, Canada

CHU de Quebec Universite Laval Hopital de l Enfant Jesus

Québec, Quebec, Canada

Unite de Recherche Clinique du CISSS des Laurentides

Saint Jerome Quebec, Quebec, Canada

Peking University First Hospital

Beijing, , China

Beijing Hospital

Beijing, , China

Beijing Luhe Hospital, Capital Medical University

Beijing, , China

The First Bethune Hospital of Jilin University

Changchun, , China

Hunan Province Cancer Hospital

Changsha, , China

West China Hospital Sichuan University

Chengdu, , China

Chongqing University Cancer Hospital

Chongqing, , China

People's Hospital of Deyang City

Deyang, , China

Sun Yat Sen University Cancer Center

Guangzhou, , China

Zhejiang Provincial People's Hospital

Hangzhou, , China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, , China

Nanjing Drum Tower Hospital

Nanjing, , China

The First Affiliated Hospital of Ningbo University

Ningbo, , China

Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine

Shanghai, , China

Huadong Hospital Affiliated to Fudan University

Shanghai, , China

Shengjing Hospital Of China Medical University

Shenyang, , China

The Second Hospital Of Tianjin Medical University

Tianjin, , China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

Wuhan, , China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, , China

Yantai Yuhuangding Hospital

Yantai, , China

Henan Cancer Hospital

Zhengzhou, , China

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Krajská nemocnice Liberec a.s.

Liberec, , Czechia

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Thomayerova nemocnice, Onkologicka klinika

Prague, , Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

Polyclinique Bordeaux Nord Acquitaine

Bordeaux, , France

CHU Gabriel-Montpied

Clermont-Ferrand, , France

CHU Grenoble

Grenoble, , France

Polyclinique de Limoges - Francois Chenieux

Limoges, , France

Hôpital Edouard Herriot

Lyon, , France

CHU de Nantes hotel Dieu

Nantes, , France

CHU Nimes

Nîmes, , France

Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

Orléans, , France

Hôpital Universitaire Pitié-Salpêtrière

Paris, , France

Hopital Europeen Georges-Pompidou

Paris, , France

APHP - Hopital Bichat - Claude Bernard

Paris, , France

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, , France

Clinical La Croix Du Sud - Ramsay Santé

Quint-Fonsegrives, , France

Chu Rennes Hopital Pontchaillou

Rennes, , France

Institut de Cancerologie Strasbourg Europe ICANS

Strasbourg, , France

CHU Rangueil

Toulouse, , France

Urologische Partnerschaft Koln UPK

Cologne, , Germany

Urologicum Duisburg

Duisburg, , Germany

Universitatsklinikum Erlangen

Erlangen, , Germany

Universitatsklinikum Essen

Essen, , Germany

Universitaetsklinikum Frankfurt

Frankfurt am Main, , Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

Matthias Schulze - Germany

Markkleeberg, , Germany

Urologie Neandertal Praxis Mettmann

Mettmann, , Germany

Klinikum rechts der Isar an der Technischen Universitat Munchen

München, , Germany

Universitatsklinikum Munster

Münster, , Germany

Klinikum Nurnberg Nord

Nuremberg, , Germany

Medizinisches Versorgungszentrum - Urologie

Nuremberg, , Germany

Studienpraxis Urologie Nurtingen

Nürtingen, , Germany

Caritas-Krankenhaus St. Josef

Regensburg, , Germany

Universitat Tubingen

Tübingen, , Germany

Health Care Global Enterprises pvt Ltd

Bangalore, , India

Post Graduate Institute of Medical Education And Research PGIMER

Chandigarh, , India

Artemis Hospital

Gurugram, , India

Netaji Subhas chandra Bose Cancer Research Institute

Kolkata, , India

Tata Memorial Hospital

Mumbai, , India

CIMET s Inamdar Multispeciality Hospital

Pune, , India

Generale Regionale F. Miulli

Acquaviva delle Fonti, , Italy

Ospedale Cardinal Massaia

Asti, , Italy

Ospedale San Giuseppe Moscati di Avellino

Avellino, , Italy

Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale

Castelfranco Veneto, , Italy

Ospedale San Raffaele di Milano

Milan, , Italy

Istituto Europeo di Oncologia

Milan, , Italy

Fondazione G Pascale Istituto Nazionale Tumori IRCCS

Napoli, , Italy

Ospedale S. Maria Delle Croci

Ravenna, , Italy

Istituto Nazionale Tumori Regina Elena

Rome, , Italy

Fuji City General Hospital

Fuji-shi, , Japan

Kanazawa University Hospital

Kanazawa, , Japan

Nara Medical University Hospital

Kashihara-shi, , Japan

Kimitsu Chuo Hospital

Kisarazu-shi, , Japan

Kobe City Medical Center General Hospital

Kobe, , Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, , Japan

Nagano Municipal Hospital

Nagano, , Japan

Nagasaki University Hospital

Nagasaki, , Japan

JRC Nagasaki Genbaku Hospital

Nagasaki, , Japan

Saiseikai Narashino Hospital

Narashino-shi, , Japan

Ehime University Hospital

Toon-shi, , Japan

Toyama University Hospital

Toyama, , Japan

Yamaguchi University Hospital

Ube, , Japan

Yokohama City University Medical Center

Yokohama, , Japan

Consultorio Medico dentro del Hospital Angeles Acoxpa

Mexico City, , Mexico

Eme Red Hospitalaria

Mérida, , Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, , Mexico

Avix Investigacion Clinica S C

Monterrey, , Mexico

Oncologico Potosino

San Luis Potosí City, , Mexico

Spaarne Ziekenhuis

Hoofddorp, , Netherlands

Canisius-Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Radboud Umcn

Nijmegen, , Netherlands

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, , Poland

IN VIVO Sp. z o.o

Bydgoszcz, , Poland

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ

Lublin, , Poland

Centrum Medyczne

Piotrkow Trybunalski, , Poland

Clinical Research Center sp z o o MEDIC R s k

Poznan, , Poland

Wojewodzki Szpital Specjalistyczny im Janusza Korczaka

Słupsk, , Poland

Provita Poliklinika

Warsaw, , Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, , Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, , Poland

Ipo Coimbra

Coimbra, , Portugal

Uls Santa Maria - Hosp. Santa Maria

Lisbon, , Portugal

Uls Gaia Espinho

Vila Nova de Gaia, , Portugal

Pusan National University Hospital

Busan, , South Korea

Chungbuk National University Hospital

Cheongju-si, , South Korea

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Keimyung University Dongsan Hospital

Daegu, , South Korea

National Cancer Center

Gyeonggi-do, , South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, , South Korea

Hosp Univ A Coruna

A Coruña, , Spain

Hosp. Punta de Europa

Algeciras, , Spain

Fund. Puigvert

Barcelona, , Spain

Hosp. Puerta Del Mar

Cadiz, , Spain

Hosp. Gral. Univ. de Castellon

Castellon, , Spain

Hosp. Univ. de Bellvitge

L'Hospitalet de Llobregat, , Spain

Hosp. Univ. Lucus Augusti

Lugo, , Spain

Clinica Univ. de Navarra

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp Virgen de La Victoria

Málaga, , Spain

Hosp. Univ. Marques de Valdecilla

Santander, , Spain

Hosp. Clinico Univ. de Valencia

Valencia, , Spain

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, , Taiwan

Chang Kung Memorial Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Western General Hospital

Edinburgh, , United Kingdom

St Bartholomews Hospital

London, , United Kingdom

The Royal Marsden NHS Trust

London, , United Kingdom

Charing Cross Hospital

London, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Scunthorpe General Hospital

Scunthorpe, , United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Lister Hospital

Stevenage, , United Kingdom

Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

Truro, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; China; Czechia; France; Germany; India; Italy; Japan; Mexico; Netherlands; Poland; Portugal; South Korea; Spain; Taiwan; United Kingdom

Other Identifiers

17000139BLC3002

Identifier Type: OTHER

Identifier Source: secondary_id

2020-004506-64

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-507187-39-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109223

Identifier Type: -

Identifier Source: org_study_id