Trial Title:
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)
NCT ID:
NCT06211764
Condition:
Non-Muscle Invasive Bladder Neoplasms
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Gemcitabine
Mitomycins
Mitomycin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TAR-200
Description:
Participants will receive TAR-200 intravesically.
Arm group label:
Group A: TAR-200
Other name:
JNJ-17000139
Intervention type:
Drug
Intervention name:
Mitomycin C
Description:
Participants will receive MMC intravesically.
Arm group label:
Group B: Mitomycin C (MMC) or Gemcitabine
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Participants will receive gemcitabine intravesically.
Arm group label:
Group B: Mitomycin C (MMC) or Gemcitabine
Summary:
The purpose of this study is to compare disease free survival (DFS) in participants with
recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC)
within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or
are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of
single agent intravesical chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed diagnosis by local pathology (within 90 days of documented
informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder
cancer (HR-NMIBC) [defined as high-grade Ta or any T1, no carcinoma in situ (CIS)]
- Participants with variant histologic subtypes are allowed if tumor(s) demonstrate
urothelial (transitional cell histology) predominance. However, neuroendocrine, and
small cell variants will be excluded
- Participants must be ineligible for or have elected not to undergo Radical
Cystectomy (RC)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1,
or 2
Exclusion Criteria:
- Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC
recurrence to randomization. Additionally, presence or history of histologically
confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic
urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+)
- Presence of any bladder or urethral anatomic feature that, in the opinion of the
Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200.
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 (>4000 mL)
- Indwelling catheters are not permitted; however, intermittent catheterization is
acceptable
- Previous treatment with TAR-200
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arkansas Urology
Address:
City:
Little Rock
Zip:
72211
Country:
United States
Status:
Recruiting
Facility:
Name:
Genesis Research LLC
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Status:
Recruiting
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Irvine Medical Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Genesis Research LLC
Address:
City:
Torrance
Zip:
90503
Country:
United States
Status:
Recruiting
Facility:
Name:
Colorado Clinical Research
Address:
City:
Lakewood
Zip:
80228
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Urology Partners
Address:
City:
Riverview
Zip:
33578
Country:
United States
Status:
Recruiting
Facility:
Name:
UroPartners
Address:
City:
Chicago Ridge
Zip:
60415
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology of Indiana
Address:
City:
Carmel
Zip:
46032
Country:
United States
Status:
Recruiting
Facility:
Name:
First Urology, PSC
Address:
City:
Jeffersonville
Zip:
47130
Country:
United States
Status:
Recruiting
Facility:
Name:
Wichita Urology Group
Address:
City:
Wichita
Zip:
67226
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Urology
Address:
City:
Royal Oak
Zip:
48073
Country:
United States
Status:
Recruiting
Facility:
Name:
Specialty Clinical Research of St Louis
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Status:
Recruiting
Facility:
Name:
Associated Medical Professionals
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Status:
Recruiting
Facility:
Name:
The Urology Group
Address:
City:
Cincinnati
Zip:
45212
Country:
United States
Status:
Recruiting
Facility:
Name:
Central Ohio Urology Group
Address:
City:
Gahanna
Zip:
43230
Country:
United States
Status:
Recruiting
Facility:
Name:
Centers for Advanced Urology LLC d b a MidLantic Urology
Address:
City:
Bala-Cynwyd
Zip:
19004
Country:
United States
Status:
Recruiting
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Facility:
Name:
Low Country Urology Clinics
Address:
City:
North Charleston
Zip:
29406
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology Associates
Address:
City:
Nashville
Zip:
37209
Country:
United States
Status:
Recruiting
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology Austin
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology Clinics of North Texas
Address:
City:
Dallas
Zip:
75231
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston Metro Urology
Address:
City:
Houston
Zip:
77027
Country:
United States
Status:
Recruiting
Facility:
Name:
Spokane Urology
Address:
City:
Spokane
Zip:
99202
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinica Santa Isabel
Address:
City:
Buenos Aires
Zip:
C1406
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Investigaciones Clinico Moleculares (ICM)
Address:
City:
Caba
Zip:
C1425
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Address:
City:
Cordoba
Zip:
5000
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Centro Urologico Profesor Bengio
Address:
City:
Córdoba
Zip:
X5000KPH
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Hospital Privado de la Comunidad
Address:
City:
Mar del Plata
Zip:
B7602
Country:
Argentina
Status:
Recruiting
Facility:
Name:
AZ Sint-Jan
Address:
City:
Brugge
Zip:
8000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Cliniques Universitaires Saint Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Ziekenhuis Oost-Limburg
Address:
City:
Genk
Zip:
3600
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Algemeen ziekenhuis Maria Middelares
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Algemeen Ziekenhuis Delta
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Fundacao Pio XII
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
NAIC Nair Antunes Instituto do Cancer
Address:
City:
Bauru
Zip:
17030-495
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
Address:
City:
Campinas
Zip:
13083-872
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Liga Paranaense de Combate ao Cancer
Address:
City:
Curitiba
Zip:
81520 060
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Irmandade Santa Casa de Misericordia de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90020-090
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital da Bahia
Address:
City:
Salvador
Zip:
41810-011
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Real e Benemérita Associação Portuguesa de Beneficência
Address:
City:
Sao Paulo
Zip:
01323 900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Antonio Prudente A C Camargo Cancer Center
Address:
City:
Sao Paulo
Zip:
01509 900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
Address:
City:
São Paulo
Zip:
01308 901
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Facility:
Name:
West China School of Medicine/West China Hospital, Sichuan University
Address:
City:
Cheng Du Shi
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chong Qing
Zip:
400033
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guang Zhou Shi
Zip:
510060
Country:
China
Status:
Recruiting
Facility:
Name:
Shengjing Hospital Of China Medical University
Address:
City:
Shen Yang Shi
Zip:
110055
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Hospital Of Tianjin Medical University
Address:
City:
Tianjin
Zip:
300211
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325015
Country:
China
Status:
Recruiting
Facility:
Name:
Tongji Medical College of Huazhong University Science Technology of Medicine Health Management
Address:
City:
Wuhan
Zip:
430032
Country:
China
Status:
Recruiting
Facility:
Name:
Xi an Jiaotong University Hospital
Address:
City:
XI An Shi
Zip:
710063
Country:
China
Status:
Recruiting
Facility:
Name:
Hopital Claude Huriez
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Recruiting
Facility:
Name:
Polyclinique de Limoges - Francois Chenieux
Address:
City:
Limoges
Zip:
87000
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Zip:
13009
Country:
France
Status:
Recruiting
Facility:
Name:
APHP - Hopital Bichat - Claude Bernard
Address:
City:
Paris
Zip:
75018
Country:
France
Status:
Recruiting
Facility:
Name:
Clinique de la Croix du Sud
Address:
City:
Quint-Fonsegrives
Zip:
31130
Country:
France
Status:
Recruiting
Facility:
Name:
Chu Rennes Hopital Pontchaillou
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Foch
Address:
City:
Suresnes
Zip:
92150
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Halle Saale
Address:
City:
Halle (Saale)
Zip:
06120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Koeln
Address:
City:
Köln
Zip:
50937
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Leverkusen gGmbH
Address:
City:
Leverkusen
Zip:
51375
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Schleswig Holstein Campus Lubeck
Address:
City:
Lubeck
Zip:
23538
Country:
Germany
Status:
Recruiting
Facility:
Name:
Urologie Neandertal Praxis Mettmann
Address:
City:
Mettmann
Zip:
40822
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum der Universitaet Muenchen
Address:
City:
Munchen
Zip:
81337
Country:
Germany
Status:
Recruiting
Facility:
Name:
Ospedale San Donato
Address:
City:
Arezzo
Zip:
52100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Provinciale di Macerata
Address:
City:
Macerata
Zip:
62100
Country:
Italy
Status:
Recruiting
Facility:
Name:
San Raffaele Hospital
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Dei Tumori Di Milano
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale S. Maria Delle Croci
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Recruiting
Facility:
Name:
Universita Campus Bio-Medico di Roma
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Nazionale Tumori Regina Elena
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Clinico Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Facility:
Name:
PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Funabashi Munitiple Medical Center
Address:
City:
Chiba
Zip:
273-8588
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hakodate Goryoukaku Hospital
Address:
City:
Hakodate
Zip:
040-8611
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hyogo Prefectural Amagasaki General Medical Center
Address:
City:
Hyogo
Zip:
660-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Niigata Cancer Center Hospital
Address:
City:
Niigata
Zip:
951-8566
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Okayama Medical Center
Address:
City:
Okayama
Zip:
701-1192
Country:
Japan
Status:
Recruiting
Facility:
Name:
Toho University Sakura Medical Center
Address:
City:
Sakura
Zip:
285-8741
Country:
Japan
Status:
Recruiting
Facility:
Name:
Toranomon Hospital
Address:
City:
Tokyo
Zip:
105-8470
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yokohama City University Medical Center
Address:
City:
Yokohama
Zip:
232 0024
Country:
Japan
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Chungcheongbuk Do
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Keimyung University Dongsan Hospital
Address:
City:
Daegu
Zip:
42601
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Cancer Center
Address:
City:
Gyeonggi-do
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Jeollanam-do
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea Seoul St Mary s Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Pusan National University Yangsan Hospital
Address:
City:
Yangsan-si
Zip:
50612
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Uniwersytecki Szpital Kliniczny w Bialymstoku
Address:
City:
Bialystok
Zip:
15 276
Country:
Poland
Status:
Recruiting
Facility:
Name:
IN VIVO Sp. z o.o
Address:
City:
Bydgoszcz
Zip:
85-048
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpital Uniwersytecki w Krakowie
Address:
City:
Krakow
Zip:
30-688
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersytecki Szpital Kliniczny nr 4
Address:
City:
Lublin
Zip:
20 090
Country:
Poland
Status:
Recruiting
Facility:
Name:
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Address:
City:
Przemysl
Zip:
37-700
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpital Wojewodzki im. Sw. Lukasza SP ZOZ
Address:
City:
Tarnow
Zip:
33-100
Country:
Poland
Status:
Recruiting
Facility:
Name:
MICS Centrum Medyczne Torun
Address:
City:
Torun
Zip:
87-100
Country:
Poland
Status:
Recruiting
Facility:
Name:
Mazowiecki Szpital Onkologiczny
Address:
City:
Wieliszew
Zip:
05-135
Country:
Poland
Status:
Recruiting
Facility:
Name:
Dolnoslaskie Centrum Onkologii
Address:
City:
Wroclaw
Zip:
53 413
Country:
Poland
Status:
Recruiting
Facility:
Name:
Centrul Medical Unirea SRL
Address:
City:
Brasov
Zip:
500091
Country:
Romania
Status:
Recruiting
Facility:
Name:
Ponderas Academic Hospital
Address:
City:
Bucuresti
Zip:
014142
Country:
Romania
Status:
Recruiting
Facility:
Name:
Institutul Oncologic Ion Chiricuta
Address:
City:
Cluj-Napoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Facility:
Name:
Regina Maria
Address:
City:
Cluj-Napoca
Zip:
400117
Country:
Romania
Status:
Recruiting
Facility:
Name:
Spitalul Clinic Judetean de Urgenta Pius Brinzeu
Address:
City:
Timisoara
Zip:
300723
Country:
Romania
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Germans Trias I Pujol
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Fund. Puigvert
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Gral. Univ. Gregorio Maranon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Virgen de La Victoria
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp.Univ.Parc Tauli
Address:
City:
Sabadell
Zip:
08208
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Marques de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Clinico Univ. de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
St Bartholomews Hospital
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Salford Royal Hospital
Address:
City:
Salford
Zip:
M6 8HD
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Southampton University Hospital
Address:
City:
Southampton
Zip:
SO16 6YD
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Lister Hospital
Address:
City:
Stevenage
Zip:
SG1 4AB
Country:
United Kingdom
Status:
Recruiting
Start date:
April 9, 2024
Completion date:
April 14, 2031
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06211764
