Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06319820

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

Led by Janssen Research & Development, LLC · Updated on 2026-05-08

641

Participants Needed

193

Research Sites

454 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of intermediate-risk non-muscle invasive bladder cancer within 90 days before randomization
  • Must meet at least one of the following: Ta low grade/Grade 1 primary or recurrent, Ta low grade/Grade 2 primary or recurrent with at least one risk factor such as multiple tumors, tumor size ≥3 cm, early recurrence, frequent recurrence, or recurrence after prior adjuvant intravesical treatment
  • Presence of a susceptible FGFR mutation or fusion confirmed by urine or tumor tissue testing
  • Willingness to undergo all study procedures including multiple cystoscopies and TURBT assessments
  • Visible papillary disease must be fully resected before randomization with no disease detected on screening cystoscopy
  • Prior or concurrent second malignancy allowed if unlikely to affect safety or efficacy assessments
  • Eastern Cooperative Oncology Group performance status of 0 to 2
Not Eligible

You will not qualify if you...

  • Allergies or intolerance to Erdafitinib excipients, TAR-210 drug delivery system materials, urinary catheter materials, MMC, or Gemcitabine
  • Anatomical bladder or urethral abnormalities that may prevent safe catheter use or TAR-210 insertion
  • Polyuria with 24-hour urine volume exceeding 4000 milliliters
  • Current use of indwelling urinary catheters (intermittent catheterization allowed)
  • Major surgery or significant injury within 4 weeks prior to first dose (excluding TURBT)
  • For substudy participants, prior diagnosis of urothelial bladder carcinoma before current diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 193 locations

1

Arkansas Urology

Little Rock, Arkansas, United States, 72211

Completed

2

Genesis Research LLC

Los Alamitos, California, United States, 90720

Active, Not Recruiting

3

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Active, Not Recruiting

4

University of California Irvine Medical Center

Orange, California, United States, 92868

Active, Not Recruiting

5

Om Research LLC

San Diego, California, United States, 92123

Active, Not Recruiting

6

Genesis Research LLC 1

Sherman Oaks, California, United States, 91411

Completed

7

University of Colorado Cancer Center Anschultz Cancer Pavilion

Aurora, Colorado, United States, 80045

Completed

8

Colorado Clinical Research

Lakewood, Colorado, United States, 80228

Active, Not Recruiting

9

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Active, Not Recruiting

10

Northwestern University

Chicago, Illinois, United States, 60611

Completed

11

First Urology

Jeffersonville, Indiana, United States, 47130

Completed

12

Wichita Urology Group

Wichita, Kansas, United States, 67226

Active, Not Recruiting

13

Ochsner Health System

New Orleans, Louisiana, United States, 70121-2429

Active, Not Recruiting

14

Chesapeake Urology Research Associates

Hanover, Maryland, United States, 21076

Completed

15

Brigham And Women's Hospital

Boston, Massachusetts, United States, 02115

Completed

16

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Active, Not Recruiting

17

Comprehensive Urology

Royal Oak, Michigan, United States, 48073

Active, Not Recruiting

18

Mercy Research

St Louis, Missouri, United States, 63141

Completed

19

Specialty Clinical Research of St Louis

St Louis, Missouri, United States, 63141

Active, Not Recruiting

20

The Urology Center, PC

Omaha, Nebraska, United States, 68114

Active, Not Recruiting

21

Cancer Institute Of New Jersey

New Brunswick, New Jersey, United States, 08901

Active, Not Recruiting

22

Integrated Medical Professionals

New York, New York, United States, 10016

Completed

23

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Active, Not Recruiting

24

Associated Medical Professionals of Ny

Syracuse, New York, United States, 13210

Active, Not Recruiting

25

SUNY Upstate Med Univ

Syracuse, New York, United States, 13210

Active, Not Recruiting

26

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

Active, Not Recruiting

27

Associated Urologists of North Carolina

Raleigh, North Carolina, United States, 27612

Active, Not Recruiting

28

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States, 19004

Active, Not Recruiting

29

Keystone Urology Specialists

Lancaster, Pennsylvania, United States, 17604

Active, Not Recruiting

30

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States, 29572

Active, Not Recruiting

31

The Conrad Pearson Clinic

Germantown, Tennessee, United States, 38138

Active, Not Recruiting

32

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

Completed

33

Urology Associates

Nashville, Tennessee, United States, 37209

Active, Not Recruiting

34

Urology Austin

Austin, Texas, United States, 78745

Active, Not Recruiting

35

Urology Clinics of North Texas

Dallas, Texas, United States, 75231

Active, Not Recruiting

36

UT Southwestern

Dallas, Texas, United States, 75390

Completed

37

Houston Metro Urology

Houston, Texas, United States, 77027

Active, Not Recruiting

38

Spokane Urology

Spokane, Washington, United States, 99202

Active, Not Recruiting

39

Hospital Sirio Libanes

Buenos Aires, Argentina, C1419AHN

Active, Not Recruiting

40

Investigaciones Clinico Moleculares (ICM)

CABA, Argentina, C1425

Active, Not Recruiting

41

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina, 5000

Active, Not Recruiting

42

Centro Urologico Profesor Bengio

Córdoba, Argentina, X5000KPH

Active, Not Recruiting

43

Hospital Privado de la Comunidad

Mar del Plata, Argentina, B7602

Active, Not Recruiting

44

Sanatorio de la Mujer

Rosario, Argentina, 2000

Active, Not Recruiting

45

Medizinische Universitaet Graz

Graz, Austria, 8036

Actively Recruiting

46

Medizinische Universitat Innsbruck

Innsbruck, Austria, 6020

Actively Recruiting

47

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria, 4020

Actively Recruiting

48

Universitaetsklinikum Salzburg Landeskrankenhaus

Salzburg, Austria, 5020

Actively Recruiting

49

Medical University Vienna MUV

Vienna, Austria, 1090

Actively Recruiting

50

AZORG campus Aalst Moorselbaan

Aalst, Belgium, 9300

Actively Recruiting

51

AZ Sint-Jan

Bruges, Belgium, 8000

Actively Recruiting

52

UZ Antwerpen

Edegem, Belgium, 2650

Completed

53

AZ Maria Middelares

Ghent, Belgium, 9000

Actively Recruiting

54

Universitair Ziekenhuis Gasthuisberg

Leuven, Belgium, 3000

Active, Not Recruiting

55

Vitaz

Sint-Niklaas, Belgium, 9100

Actively Recruiting

56

CHU UCL Namur - Site Godinne

Yvoir, Belgium, 5530

Actively Recruiting

57

Fundacao Pio XII

Barretos, Brazil, 14780-070

Active, Not Recruiting

58

Universidade Estadual De Campinas

Campinas, Brazil, 13083-888

Completed

59

Liga Norte Riograndense Contra O Cancer

Natal, Brazil, 59062 000

Active, Not Recruiting

60

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Brazil, 90035-001

Active, Not Recruiting

61

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90050170

Active, Not Recruiting

62

HBA SA Assitencia Medica e Hospitalar

Salvador, Brazil, 41810-011

Active, Not Recruiting

63

Fundacao do ABC Centro Universitario FMABC

Santo André, Brazil, 09060 870

Active, Not Recruiting

64

Irmandade Da Santa Casa De Misericordia De Sao Paulo

São Paulo, Brazil, 01221-020

Active, Not Recruiting

65

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

São Paulo, Brazil, 01246-000

Active, Not Recruiting

66

Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, Brazil, 01323 900

Active, Not Recruiting

67

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil, 01509 900

Completed

68

Beijing Friendship Hospital Capital Medical University

Beijing, China, 100050

Active, Not Recruiting

69

Peking University Third Hospital

Beijing, China, 100191

Active, Not Recruiting

70

Hunan Cancer hospital

Changsha, China, 410013

Active, Not Recruiting

71

The Third People's Hospital of Chengdu

Cheng Du Shi, China, 610014

Active, Not Recruiting

72

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

Cheng Du Shi, China, 610041

Active, Not Recruiting

73

Chongqing Cancer Hospital

Chongqing, China, 400033

Active, Not Recruiting

74

Fujian Medical University Union Hospital

Fuzhou, China, 350001

Active, Not Recruiting

75

Sun Yat Sen University Cancer Center

Guangzhou, China, 510060

Active, Not Recruiting

76

Nanjing Drum Tower Hospital

Nanjing, China, 210008

Active, Not Recruiting

77

Zhongda Hospital Southeast University

Nanjing, China, 210009

Active, Not Recruiting

78

Huadong Hospital Affiliated to Fudan University

Shanghai, China, 200031

Active, Not Recruiting

79

The Second Hospital Of Tianjin Medical University

Tianjin, China, 300061

Active, Not Recruiting

80

Cancer Hospital of Xinjiang Medical University

Ürümqi, China, 830011

Active, Not Recruiting

81

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China, 325000

Active, Not Recruiting

82

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

Wuhan, China, 430032

Active, Not Recruiting

83

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China, 710063

Active, Not Recruiting

84

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China, 221004

Active, Not Recruiting

85

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia, 500 05

Completed

86

Fakultni nemocnice Olomouc

Olomouc, Czechia, 779 00

Actively Recruiting

87

Vseobecna fakultni nemocnice v Praze

Prague, Czechia, 128 08

Actively Recruiting

88

Fakultni Thomayerova nemocnice

Prague, Czechia, 140 59

Actively Recruiting

89

Fakultni nemocnice v Motole

Prague, Czechia, 150 06

Actively Recruiting

90

Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

91

Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

92

Herlev Hospital

Herlev, Denmark, 2730

Actively Recruiting

93

Odense Universitetshospital

Odense, Denmark, 5000

Actively Recruiting

94

Zealand University Hospital

Roskilde, Denmark, 4000

Actively Recruiting

95

Hospital Center University De Lille

Lille, France, 59000

Completed

96

Polyclinique de Limoges - Francois Chenieux

Limoges, France, 87000

Actively Recruiting

97

Hôpital Edouard Herriot

Lyon, France, 69003

Actively Recruiting

98

Institut Paoli Calmettes

Marseille, France, 13009

Actively Recruiting

99

Hopital Saint Louis

Paris, France, 75010

Actively Recruiting

100

CHU Pitie Salpetriere

Paris, France, 75013

Actively Recruiting

101

APHP - Hopital Bichat - Claude Bernard

Paris, France, 75018

Actively Recruiting

102

Clinique de la Croix du Sud

Quint-Fonsegrives, France, 31130

Actively Recruiting

103

Chu Rennes Hopital Pontchaillou

Rennes, France, 35000

Completed

104

CHU Rangueil

Toulouse, France, 31059

Actively Recruiting

105

Institut Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

106

Charite - Universitaetsmedizin Berlin (CCM)

Berlin, Germany, 10117

Active, Not Recruiting

107

Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie

Braunschweig, Germany, 38126

Actively Recruiting

108

Studienzentrum Bayenthal

Cologne, Germany, 50968

Actively Recruiting

109

Urologische Gemeinschaftspraxis

Dresden, Germany, 01307

Completed

110

Universitaetsklinikum Frankfurt

Frankfurt am Main, Germany, 60596

Actively Recruiting

111

Urologikum Hamburg MVZ - Germany

Hamburg, Germany, 22081

Active, Not Recruiting

112

Marien hospital Herne

Herne, Germany, 44625

Actively Recruiting

113

Universitatsklinikum Jena

Jena, Germany, 07747

Active, Not Recruiting

114

Klinikum rechts der Isar an der Technischen Universitat Munchen

München, Germany, 81675

Completed

115

Klinikum St. Elisabeth Straubing GmbH

Straubing, Germany, 94315

Actively Recruiting

116

Katharinenhospital Innere Medizin

Stuttgart, Germany, 70174

Completed

117

Prince Of Wales Hospital

Hong Kong, Hong Kong

Active, Not Recruiting

118

Queen Mary Hospital

Hong Kong, Hong Kong

Active, Not Recruiting

119

Cork University Hospital

Cork, Ireland, T12 DC4A

Active, Not Recruiting

120

Mater Misericordiae University Hospital

Dublin, Ireland, D07 A8NN

Active, Not Recruiting

121

Mater Private Hospital

Dublin, Ireland, D07 WKW8

Active, Not Recruiting

122

Adelaide and Meath Hospital

Dublin, Ireland, D24 NR0A

Active, Not Recruiting

123

Rambam Health Care Campus

Haifa, Israel, 3109601

Actively Recruiting

124

Hadassah University Hospita Ein Kerem

Jerusalem, Israel, 9112001

Completed

125

Sheba Medical Center

Ramat Gan, Israel, 5262000

Actively Recruiting

126

Ziv Medical Center

Safed, Israel, 13100

Actively Recruiting

127

Sourasky Medical Center

Tel Aviv, Israel, 6423906

Actively Recruiting

128

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

Arezzo, Italy, 52100

Actively Recruiting

129

Cliniche Humanitas Gavazzeni

Bergamo, Italy, 24125

Actively Recruiting

130

ASST Spedali Civili Brescia

Brescia, Italy, 25123

Actively Recruiting

131

Ospedale San Raffaele

Milan, Italy, 20132

Completed

132

Istituto Dei Tumori Di Milano

Milan, Italy, 20133

Actively Recruiting

133

Universita Campus Bio-Medico di Roma

Roma, Italy, 00128

Actively Recruiting

134

Istituto Nazionale Tumori Regina Elena

Roma, Italy, 00144

Actively Recruiting

135

Istituto Clinico Humanitas

Rozzano, Italy, 20089

Actively Recruiting

136

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

Torino, Italy, 10126

Actively Recruiting

137

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki Shi, Japan, 660 8550

Active, Not Recruiting

138

St Marianna University Hospital

Kawasaki Shi, Japan, 216 8511

Actively Recruiting

139

Kobe City Medical Center General Hospital

Kobe, Japan, 650 0047

Active, Not Recruiting

140

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan, 860 0008

Active, Not Recruiting

141

Osaka International Cancer Institute

Osaka, Japan, 541 8567

Actively Recruiting

142

Gunma Prefectural Cancer Center

Ōta-ku, Japan, 373 8550

Actively Recruiting

143

Saitama Medical Center

Saitama, Japan, 350 8550

Active, Not Recruiting

144

JRC Wakayama Medical Center

Wakayama, Japan, 640 8558

Active, Not Recruiting

145

Yokohama Municipal Citizen's Hospital

Yokohama, Japan, 221 0855

Actively Recruiting

146

Yokohama City University Medical Center

Yokohama, Japan, 232 0024

Active, Not Recruiting

147

Yokosuka Kyosai Hospital

Yokosuka, Japan, 238 8558

Actively Recruiting

148

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland, 15 276

Actively Recruiting

149

IN VIVO Sp. z o.o

Bydgoszcz, Poland, 85 048

Actively Recruiting

150

Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

Bydgoszcz, Poland, 85 796

Completed

151

Uniwersytecki Szpital Kliniczny nr 4

Lublin, Poland, 20 090

Actively Recruiting

152

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

Przemyśl, Poland, 37 700

Active, Not Recruiting

153

Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie

Tarnów, Poland, 33-100

Actively Recruiting

154

Medicover Integrated Clinical Services Sp z o o

Torun, Poland, 87-100

Completed

155

Mazowiecki Szpital Onkologiczny Sp z o o

Wieliszew, Poland, 05-135

Actively Recruiting

156

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

Wroclaw, Poland, 50 981

Completed

157

Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii

Wroclaw, Poland, 53-413

Actively Recruiting

158

Chungbuk National University Hospital

Chungcheongbuk Do, South Korea, 28644

Completed

159

National Cancer Center

Gyeonggi-do, South Korea, 10408

Actively Recruiting

160

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea, 58128

Actively Recruiting

161

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

162

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea, 06591

Active, Not Recruiting

163

Seoul National University Hospital

Seoul, South Korea, 3080

Actively Recruiting

164

Hosp Univ A Coruna

A Coruña, Spain, 15006

Actively Recruiting

165

Hosp. Univ. de La Ribera

Alzira, Spain, 46600

Actively Recruiting

166

Fund. Puigvert

Barcelona, Spain, 08025

Actively Recruiting

167

Hosp Univ Vall D Hebron

Barcelona, Spain, 08035

Completed

168

Hosp Clinic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

169

Hosp. Puerta Del Mar

Cadiz, Spain, 11009

Actively Recruiting

170

Hosp. Gral. Univ. de Castellon

Castellon, Spain, 12004

Actively Recruiting

171

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain, 11407

Actively Recruiting

172

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain, 28007

Completed

173

Clinica Univ. de Navarra

Madrid, Spain, 28027

Actively Recruiting

174

Hosp. Univ. 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

175

Hosp Virgen de La Victoria

Málaga, Spain, 29010

Actively Recruiting

176

Hosp. Univ. Central de Asturias

Oviedo, Spain, 33011

Completed

177

Hosp.Univ.Parc Tauli

Sabadell, Spain, 08208

Actively Recruiting

178

Hosp. Virgen Del Rocio

Seville, Spain, 41013

Completed

179

Hosp. Clinico Univ. de Valencia

Valencia, Spain, 46010

Actively Recruiting

180

Adana Baskent Practice and Research Hospital

Adana, Turkey (Türkiye), 01120

Completed

181

Ankara University Medical Faculty

Ankara, Turkey (Türkiye), 06100

Completed

182

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye), 06200

Actively Recruiting

183

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye), 34153

Completed

184

T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

Istanbul, Turkey (Türkiye), 34722

Actively Recruiting

185

Kartal Dr Lutfi Kirdar sehir Hastanesi

Istanbul, Turkey (Türkiye), 34865

Actively Recruiting

186

Dokuz Eylul University Medical Faculty

Izmir, Turkey (Türkiye), 35330

Actively Recruiting

187

Southmead Hospital

Bristol, United Kingdom, BS105NB

Actively Recruiting

188

St Bartholomews Hospital

London, United Kingdom, EC1A 7BE

Actively Recruiting

189

Charing Cross Hospital

London, United Kingdom, W6 8RF

Actively Recruiting

190

Newcastle Freeman Hospital

Newcastle upon Tyne, United Kingdom, NE7 7DN

Actively Recruiting

191

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom, S10 2SJ

Actively Recruiting

192

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Actively Recruiting

193

Royal Marsden Hospital

Sutton, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

S

Study Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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