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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,135

Participants

Timeline

Start Date

March 23, 2023

Primary Completion Date

September 18, 2029

Study Completion Date

September 18, 2029

Conditions
Bladder Cancer
Interventions
DRUG

TAR-200

TAR-200 will be administered intravesically.

BIOLOGICAL

Cetrelimab

Cetrelimab will be administered.

BIOLOGICAL

BCG Vesiculture

BCG will be administered intravesically.

Trial Locations (240)

404

China Medical University Hospital, Taichung

807

Kaohsiung Medical University Chung Ho Memorial Hospital, Kaohsiung City

833

Chang Kung Memorial Hospital, Kaohsiung City

2020

ZNA Middelheim, Antwerp

2109

Macquarie University Hospital, Macquarie University

2610

GZA Ziekenhuizen- Campus St Augustinus, Wilrijk

3084

Austin Health, Heidelberg

4101

Mater Hospital Brisbane, South Brisbane

5000

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica, Córdoba

5800

Instituto Medico Rio Cuarto, Río Cuarto

6009

Hollywood Private Hospital, Nedlands

6800

Centre Hospitalier de l'Ardenne, Libramont-Chevigny

8000

AZ Sint-Jan, Bruges

8310

AZ Sint-Lucas, Bruges

8800

AZ Delta, Roeselare

9000

AZ Maria Middelares, Ghent

UZ Gent, Ghent

9100

Vitaz, Sint-Niklaas

10010

VA NY Harbor Healthcare System, New York

10029

Icahn School of Medicine at Mt. Sinai, New York

10408

National Cancer Center, Gyeonggi-do

11009

Hosp. Puerta Del Mar, Cadiz

11207

Hosp. Punta de Europa, Algeciras

11217

Taipei Veterans General Hospital, Taipei

12004

Hosp. Gral. Univ. de Castellon, Castellon

13210

Associated Medical Professionals of Ny, Syracuse

SUNY Upstate Med Univ, Syracuse

14100

Ospedale Cardinal Massaia, Asti

14308

Consultorio Medico dentro del Hospital Angeles Acoxpa, Mexico City

15006

Fakultni nemocnice v Motole, Prague

Hosp Univ A Coruna, A Coruña

15232

UPMC Shadyside Hospital, Pittsburgh

19004

Centers for Advanced Urology LLC d b a MidLantic Urology, Bala-Cynwyd

19107

Thomas Jefferson University Hospital, Philadelphia

20132

Ospedale San Raffaele di Milano, Milan

20141

Istituto Europeo di Oncologia, Milan

21076

Chesapeake Urology Research Associates, Hanover

23462

Urology Of Virginia, Pllc, Virginia Beach

27003

Hosp. Univ. Lucus Augusti, Lugo

27834

Vidant Urology - Greenville, Greenville

28027

Clinica Univ. de Navarra, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. La Paz, Madrid

28644

Chungbuk National University Hospital, Cheongju-si

29010

Hosp Virgen de La Victoria, Málaga

29572

Carolina Urologic Research Center, Myrtle Beach

30029

CHU Nimes, Nîmes

30303

Grady Memorial Hospital, Atlanta

30322

The Emory Clinic Department of Urology, Atlanta

31033

Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale, Castelfranco Veneto

31059

CHU Rangueil, Toulouse

31130

Clinical La Croix Du Sud - Ramsay Santé, Quint-Fonsegrives

32806

Orlando Health Cancer Institute, Orlando

33000

Polyclinique Bordeaux Nord Acquitaine, Bordeaux

33016

Urological Research Network, Hialeah

33382

Linkou Chang Gung Memorial Hospital, Taoyuan District

34239

Sarasota Memorial Hospital, Sarasota

35000

Chu Rennes Hopital Pontchaillou, Rennes

37209

Urology Associates, Nashville

37232

Vanderbilt University Medical Center, Nashville

38043

CHU Grenoble, Grenoble

39008

Hosp. Univ. Marques de Valdecilla, Santander

40705

Taichung Veterans General Hospital, Taichung

40822

Urologie Neandertal Praxis Mettmann, Mettmann

41404

Kyungpook National University Chilgok Hospital, Daegu

42601

Keimyung University Dongsan Hospital, Daegu

43230

Central Ohio Urology Group, Gahanna

44093

CHU de Nantes hotel Dieu, Nantes

44195

Cleveland Clinic, Cleveland

45067

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

45147

Universitatsklinikum Essen, Essen

46010

Hosp. Clinico Univ. de Valencia, Valencia

46032

Urology of Indiana, Carmel

47130

First Urology, Jeffersonville

47169

Urologicum Duisburg, Duisburg

48109

University of Michigan, Ann Arbor

48121

Ospedale S. Maria Delle Croci, Ravenna

48149

Universitatsklinikum Munster, Münster

49241

Pusan National University Hospital, Busan

50968

Urologische Partnerschaft Koln UPK, Cologne

55455

University Of Minnesota, Minneapolis

55905

Mayo Clinic Rochester, Rochester

58128

Chonnam National University Hwasun Hospital, Jeollanam-do

60532

Duly Health and Care, Lisle

60590

Universitaetsklinikum Frankfurt, Frankfurt am Main

60611

Northwestern University, Chicago

62301

Blessing Hospital, Quincy

63003

CHU Gabriel-Montpied, Clermont-Ferrand

64460

Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey

64710

Avix Investigacion Clinica S C, Monterrey

65691

Fakultni nemocnice u sv. Anny v Brne, Brno

66204

AMR Kansas City Oncology, Merriam

67200

Institut de Cancerologie Strasbourg Europe ICANS, Strasbourg

67226

Wichita Urology Group, Wichita

68114

The Urology Center, PC, Omaha

69437

Hôpital Edouard Herriot, Lyon

70021

Generale Regionale F. Miulli, Acquaviva delle Fonti

72076

Universitat Tubingen, Tübingen

72211

Arkansas Urology, Little Rock

72622

Studienpraxis Urologie Nurtingen, Nürtingen

75013

Hôpital Universitaire Pitié-Salpêtrière, Paris

75015

Hopital Europeen Georges-Pompidou, Paris

75018

APHP - Hopital Bichat - Claude Bernard, Paris

75231

Urology Clinics of North Texas, Dallas

75960

Groupe Hospitalier Diaconesses Croix Saint Simon, Paris

77027

Houston Metro Urology, Houston

77030

Houston Methodist Hospital, Houston

78229

Urology San Antonio Research, San Antonio

78260

Oncologico Potosino, San Luis Potosí City

78745

Urology Austin, Austin

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

80138

Fondazione G Pascale Istituto Nazionale Tumori IRCCS, Napoli

80228

Colorado Clinical Research, Lakewood

81675

Klinikum rechts der Isar an der Technischen Universitat Munchen, München

83100

Ospedale San Giuseppe Moscati di Avellino, Avellino

84112

Huntsman Cancer Institute, Salt Lake City

84148

George E. Wahlen VAMC, Salt Lake City

85259

Mayo Clinic, Scottsdale

87000

Polyclinique de Limoges - Francois Chenieux, Limoges

90048

Cedars Sinai Medical Center, Los Angeles

90404

Providence Saint Johns Cancer Institute, Santa Monica

90419

Klinikum Nurnberg Nord, Nuremberg

90491

Medizinisches Versorgungszentrum - Urologie, Nuremberg

90720

Genesis Research, LLC - West Coast Urology, Los Alamitos

90822

VA Long Beach Health Care System, Long Beach

91054

Universitatsklinikum Erlangen, Erlangen

92123

Genesis Research, San Diego

93053

Caritas-Krankenhaus St. Josef, Regensburg

95403

Providence Medical Foundation, Santa Rosa

95630

UC Davis Comprehensive Cancer Center, Sacramento

97000

Eme Red Hospitalaria, Mérida

99202

Spokane Urology, Spokane

100034

Peking University First Hospital, Beijing

100730

Beijing Hospital, Beijing

101100

Beijing Luhe Hospital, Capital Medical University, Beijing

110004

Shengjing Hospital Of China Medical University, Shenyang

122001

Artemis Hospital, Gurugram

130499

The First Bethune Hospital of Jilin University, Changchun

160012

Post Graduate Institute of Medical Education And Research PGIMER, Chandigarh

200025

Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine, Shanghai

200400

Huadong Hospital Affiliated to Fudan University, Shanghai

210008

Nanjing Drum Tower Hospital, Nanjing

264000

Yantai Yuhuangding Hospital, Yantai

300211

The Second Hospital Of Tianjin Medical University, Tianjin

310000

Zhejiang Provincial People's Hospital, Hangzhou

310016

Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou

315010

The First Affiliated Hospital of Ningbo University, Ningbo

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

400000

Chongqing University Cancer Hospital, Chongqing

400012

Tata Memorial Hospital, Mumbai

410013

Hunan Province Cancer Hospital, Changsha

411040

CIMET s Inamdar Multispeciality Hospital, Pune

430030

Sun Yat Sen University Cancer Center, Guangzhou

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

450008

Henan Cancer Hospital, Zhengzhou

560027

Health Care Global Enterprises pvt Ltd, Bangalore

610044

West China Hospital Sichuan University, Chengdu

618000

People's Hospital of Deyang City, Deyang

700094

Netaji Subhas chandra Bose Cancer Research Institute, Kolkata

710061

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

01805

Lahey Hospital & Medical Center, Burlington

08103

Cooper Health System MD Anderson Cancer Center at Cooper, Camden

C1199

Hospital Italiano de Buenos Aires, Buenos Aires

C1417

Sociedade Beneficente de Senhoras Hospital Sirio Libanes, Buenos Aires

X5000KPH

Centro Urologico Profesor Bengio, Córdoba

X5016KEH

Hospital Privado Centro Medico de Cordoba, Córdoba

B7602CBM

Hospital Privado de la Comunidad, Mar del Plata

14784-400

Fundacao Pio XII, Barretos

17033-495

NAIC Nair Antunes Instituto do Cancer, Bauru

13083-888

Universidade Estadual De Campinas, Campinas

81520 060

Liga Paranaense de Combate ao Cancer, Curitiba

59075-740

Liga Norte Riograndense Contra O Cancer, Natal

90050-170

Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre

19013-050

Hospital Regional do Cancer - Hospital de Esperança, Presidente Prudente

41253 190

Hospital Sao Rafael, Salvador

96835-090

Hospital Ana Nery Santa Cruz do Sul, Santa Cruz do Sul

09060-870

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia, Santo André

01246 000

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

01508-010

Fundacao Antonio Prudente A C Camargo Cancer Center, São Paulo

05652 900

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo

1321 001

Real e Benemerita Associacao Portuguesa de Beneficencia, São Paulo

B3H 2Y9

Nova Scotia Health Authority, Halifax

L8N 4A6

St Josephs Healthcare Hamilton, Hamilton

M5G 1Z5

Princess Margaret Cancer Centre University Health Network, Toronto

H2X 3E4

CHUM - Centre hospitalier universitaire de Montreal, Montreal

G1J1Z4

CHU de Quebec Universite Laval Hopital de l Enfant Jesus, Québec

J7Z 2V4

Unite de Recherche Clinique du CISSS des Laurentides, Saint Jerome Quebec

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

460 01

Krajská nemocnice Liberec a.s., Liberec

779 00

Fakultni nemocnice Olomouc, Olomouc

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

140 59

Thomayerova nemocnice, Onkologicka klinika, Prague

04416

Matthias Schulze - Germany, Markkleeberg

00128

Istituto Nazionale Tumori Regina Elena, Rome

417-8567

Fuji City General Hospital, Fuji-shi

920 8641

Kanazawa University Hospital, Kanazawa

634-8522

Nara Medical University Hospital, Kashihara-shi

292-8535

Kimitsu Chuo Hospital, Kisarazu-shi

650 0047

Kobe City Medical Center General Hospital, Kobe

860-0008

National Hospital Organization Kumamoto Medical Center, Kumamoto

381-8551

Nagano Municipal Hospital, Nagano

852-8501

Nagasaki University Hospital, Nagasaki

852-8511

JRC Nagasaki Genbaku Hospital, Nagasaki

275-8580

Saiseikai Narashino Hospital, Narashino-shi

791-0295

Ehime University Hospital, Toon-shi

930 0194

Toyama University Hospital, Toyama

755-8505

Yamaguchi University Hospital, Ube

232 0024

Yokohama City University Medical Center, Yokohama

2134 TM

Spaarne Ziekenhuis, Hoofddorp

6524 KD

Canisius-Wilhelmina Ziekenhuis, Nijmegen

6525 GA

Radboud Umcn, Nijmegen

15 276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

85 048

IN VIVO Sp. z o.o, Bydgoszcz

20 708

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ, Lublin

97 300

Centrum Medyczne, Piotrkow Trybunalski

61 731

Clinical Research Center sp z o o MEDIC R s k, Poznan

76-200

Wojewodzki Szpital Specjalistyczny im Janusza Korczaka, Słupsk

02-647

Provita Poliklinika, Warsaw

02-781

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warsaw

50 556

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

3000-075

Ipo Coimbra, Coimbra

1649 028

Uls Santa Maria - Hosp. Santa Maria, Lisbon

4434 502

Uls Gaia Espinho, Vila Nova de Gaia

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08025

Fund. Puigvert, Barcelona

08907

Hosp. Univ. de Bellvitge, L'Hospitalet de Llobregat

EH4 2XU

Western General Hospital, Edinburgh

EC1A 7BE

St Bartholomews Hospital, London

SW3 6JJ

The Royal Marsden NHS Trust, London

W6 8RF

Charing Cross Hospital, London

PL6 8DH

Derriford Hospital, Plymouth

DN15 7BH

Scunthorpe General Hospital, Scunthorpe

S10 2JF

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

SG1 4AB

Lister Hospital, Stevenage

TR1 3LJ

Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital, Truro

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