A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

April 9, 2024

Primary Completion Date

November 27, 2030

Study Completion Date

April 14, 2031

Conditions
Non-Muscle Invasive Bladder Neoplasms
Interventions
DRUG

TAR-200

Participants will receive TAR-200 intravesically.

DRUG

Mitomycin C

Participants will receive MMC intravesically.

DRUG

Gemcitabine

Participants will receive gemcitabine intravesically.

Trial Locations (123)

1200

Cliniques Universitaires Saint Luc, Brussels

3600

Ziekenhuis Oost-Limburg, Genk

5000

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

8000

AZ Sint-Jan, Bruges

8800

Algemeen Ziekenhuis Delta, Roeselare

9000

Algemeen ziekenhuis Maria Middelares, Ghent

10126

PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino, Torino

10408

National Cancer Center, Gyeonggi-do

13009

Institut Paoli Calmettes, Marseille

13210

Associated Medical Professionals, Syracuse

19004

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

20089

Istituto Clinico Humanitas, Rozzano

20132

San Raffaele Hospital, Milan

20133

Istituto Dei Tumori Di Milano, Milan

23538

Universitatsklinikum Schleswig Holstein Campus Lubeck, Lübeck

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28644

Chungbuk National University Hospital, Chungcheongbuk Do

29010

Hosp Virgen de La Victoria, Málaga

29401

Ralph H. Johnson Veterans Affairs Medical Center, Charleston

29406

Low Country Urology Clinics, North Charleston

29572

Carolina Urologic Research Center, Myrtle Beach

31130

Clinique de la Croix du Sud, Quint-Fonsegrives

33578

Florida Urology Partners, Riverview

35000

Chu Rennes Hopital Pontchaillou, Rennes

37209

Urology Associates, Nashville

37232

Vanderbilt University Medical Center, Nashville

39008

Hosp. Univ. Marques de Valdecilla, Santander

40822

Urologie Neandertal Praxis Mettmann, Mettmann

41013

Hosp. Virgen Del Rocio, Seville

42601

Keimyung University Dongsan Hospital, Daegu

43230

Central Ohio Urology Group, Gahanna

45212

The Urology Group, Cincinnati

46010

Hosp. Clinico Univ. de Valencia, Valencia

46032

Urology of Indiana, Carmel

47130

First Urology, PSC, Jeffersonville

48073

Comprehensive Urology, Royal Oak

48121

Ospedale S. Maria Delle Croci, Ravenna

50612

Pusan National University Yangsan Hospital, Yangsan

50937

Universitaetsklinikum Koeln, Cologne

51375

Klinikum Leverkusen gGmbH, Leverkusen

52100

Ospedale San Donato, Arezzo

58128

Chonnam National University Hwasun Hospital, Jeollanam-do

59000

Hopital Claude Huriez, Lille

60415

UroPartners, Chicago Ridge

60611

Northwestern University, Chicago

62100

Ospedale Provinciale di Macerata, Macerata

63141

Specialty Clinical Research of St Louis, St Louis

67226

Wichita Urology Group, Wichita

72211

Arkansas Urology, Little Rock

75018

APHP - Hopital Bichat - Claude Bernard, Paris

75231

Urology Clinics of North Texas, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

77027

Houston Metro Urology, Houston

78745

Urology Austin, Austin

80228

Colorado Clinical Research, Lakewood

81377

Klinikum der Universitaet Muenchen, München

87000

Polyclinique de Limoges - Francois Chenieux, Limoges

90033

USC Norris Comprehensive Cancer Center, Los Angeles

90503

Genesis Research LLC, Torrance

90720

Genesis Research LLC, Los Alamitos

92150

Hopital Foch, Suresnes

92868

University of California Irvine Medical Center, Orange

99202

Spokane Urology, Spokane

100034

Peking University First Hospital, Beijing

110055

Shengjing Hospital Of China Medical University, Shenyang

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

300211

The Second Hospital Of Tianjin Medical University, Tianjin

300723

Spitalul Clinic Judetean de Urgenta Pius Brinzeu, Timișoara

325015

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

400015

Institutul Oncologic Ion Chiricuta, Cluj-Napoca

400033

Chongqing Cancer Hospital, Chongqing

400117

Regina Maria, Cluj-Napoca

430032

Tongji Medical College of Huazhong University Science Technology of Medicine Health Management, Wuhan

500091

Centrul Medical Unirea SRL, Brasov

510060

Sun Yat Sen University Cancer Center, Guangzhou

610041

West China School of Medicine/West China Hospital, Sichuan University, Cheng Du Shi

710063

Xi an Jiaotong University Hospital, Xi'an

94158 2549

University of California San Francisco, San Francisco

C1406

Clinica Santa Isabel, Buenos Aires

C1425

Investigaciones Clinico Moleculares (ICM), CABA

X5000KPH

Centro Urologico Profesor Bengio, Córdoba

B7602

Hospital Privado de la Comunidad, Mar del Plata

14784-400

Fundacao Pio XII, Barretos

17030-495

NAIC Nair Antunes Instituto do Cancer, Bauru

13083-872

Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP, Campinas

81520 060

Liga Paranaense de Combate ao Cancer, Curitiba

90020-090

Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre

41810-011

Hospital da Bahia, Salvador

01308 901

Sociedade Beneficente de Senhoras Hospital Sirio Libanes, São Paulo

01323 900

Real e Benemérita Associação Portuguesa de Beneficência, São Paulo

01509 900

Fundacao Antonio Prudente A C Camargo Cancer Center, São Paulo

06120

Universitaetsklinikum Halle Saale, Halle

00128

Universita Campus Bio-Medico di Roma, Roma

00144

Istituto Nazionale Tumori Regina Elena, Roma

273 8588

Funabashi Municipal Medical Center, Funabashi Shi

040 8611

Hakodate Goryoukaku Hospital, Hakodate

660-8550

Hyogo Prefectural Amagasaki General Medical Center, Hyōgo

951-8566

Niigata Cancer Center Hospital, Niigata

701-1192

National Hospital Organization Okayama Medical Center, Okayama

285-8741

Toho University Sakura Medical Center, Sakura

105-8470

Toranomon Hospital, Tokyo

232 0024

Yokohama City University Medical Center, Yokohama

15 276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

85 048

IN VIVO Sp. z o.o, Bydgoszcz

30 688

Szpital Uniwersytecki w Krakowie, Krakow

20 090

Uniwersytecki Szpital Kliniczny nr 4, Lublin

37 700

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu, Przemyśl

33 100

Szpital Wojewodzki im Sw Lukasza SP ZOZ, Tarnów

87-100

MICS Centrum Medyczne Torun, Torun

05-135

Mazowiecki Szpital Onkologiczny, Wieliszew

53 413

Dolnoslaskie Centrum Onkologii, Wroclaw

014142

Ponderas Academic Hospital, Bucharest

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Mary s Hospital, Seoul

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

08025

Fund. Puigvert, Barcelona

08208

Hosp.Univ.Parc Tauli, Sabadell

EC1A 7BE

St Bartholomews Hospital, London

M6 8HD

Salford Royal Hospital, Salford

SO16 6YD

Southampton University Hospital, Southampton

SG1 4AB

Lister Hospital, Stevenage

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT06211764 - A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG) | Biotech Hunter | Biotech Hunter