Phase
Condition
Urothelial Cancer
Bladder Cancer
Treatment
Gemcitabine
MMC
TAR-210
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a histologically confirmed diagnosis (within 90 days of randomization) ofIR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c.Greater than or equal to (>=) 1 of the following risk factors: i. Multiple Ta LGtumors, ii. Solitary LG tumor >= 3 cm, iii. Early recurrence (less than [<] 1 year),iv. Frequent recurrence (greater than [>] 1 per year), v. Recurrence after prioradjuvant intravesical treatment (single perioperative dose of chemotherapy does notfulfill this risk factor)
Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusioneither by urine testing or tumor tissue testing (from TURBT tissue), as determinedby central or local testing
Participants must be willing to undergo all study procedures (e.g., multiplecystoscopies from Screening through the end of study and TURBT for assessment ofrecurrence/progression) and receive the assigned treatment, including intravesicalchemotherapy if randomized into that arm.
Visible papillary disease must be fully resected prior to randomization and absenceof disease must be documented at Screening cystoscopy
Can have a prior or concurrent second malignancy (other than the disease understudy) which natural history or treatment is unlikely to interfere with any studyendpoints of safety or the efficacy of the study treatment
Have an Eastern Cooperative Oncology Group performance status of 0 to 2
Exclusion
Exclusion Criteria:
Known allergies, hypersensitivity, or intolerance to any study component or itsexcipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery systemconstituent materials ; c. urinary placement catheter materials; d. MMC orchemically related drugs; e. Gemcitabine or chemically related drugs
Presence of any bladder or urethral anatomic feature (that is, urethral stricture)that, in the opinion of the investigator, may prevent the safe insertion, indwellinguse, removal of TAR-210 or passage of a urethral catheter for intravesicalchemotherapy
Polyuria with recorded 24-hour urine volumes > 4000 milliliters (mL)
Current indwelling urinary catheters, however, intermittent catheterization isacceptable
Had major surgery or had significant traumatic injury and/or not fully recoveredwithin 4 weeks before first dose (TURBT is not considered major surgery)
Study Design
Connect with a study center
Investigaciones Clinico Moleculares (ICM)
Caba, C1425
ArgentinaActive - Recruiting
Hospital Sirio Libanes
Ciudad Autonoma de Buenos Aires, C1419AHN
ArgentinaActive - Recruiting
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Cordoba, 5000
ArgentinaActive - Recruiting
Centro Urologico Profesor Bengio
Córdoba, X5000KPH
ArgentinaActive - Recruiting
Hospital Privado de la Comunidad
Mar del Plata, B7602
ArgentinaActive - Recruiting
Sanatorio de la Mujer
Rosario, 2000
ArgentinaActive - Recruiting
Medizinische Universitaet Graz
Graz, 8036
AustriaActive - Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
AustriaActive - Recruiting
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, 5020
AustriaActive - Recruiting
Medical University Vienna MUV
Wien, 1090
AustriaActive - Recruiting
Onze -Lieve-Vrouwziekenhuis
Aalst, 9300
BelgiumActive - Recruiting
AZ Sint-Jan
Brugge, 8000
BelgiumActive - Recruiting
UZ Antwerpen
Edegem, 2650
BelgiumActive - Recruiting
AZ Maria Middelares
Gent, 9000
BelgiumActive - Recruiting
Universitair Ziekenhuis Gasthuisberg
Leuven, 3000
BelgiumActive - Recruiting
Vitaz
Sint Niklaas, 9100
BelgiumActive - Recruiting
Vitaz
Sint-Niklaas, 9100
BelgiumSite Not Available
CHU UCL Namur - Site Godinne
Yvoir, 5530
BelgiumActive - Recruiting
Fundacao Pio XII
Barretos, 14780-070
BrazilActive - Recruiting
Universidade Estadual De Campinas
Campinas, 13083-888
BrazilActive - Recruiting
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000
BrazilActive - Recruiting
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035-001
BrazilActive - Recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050170
BrazilActive - Recruiting
HBA SA Assitencia Medica e Hospitalar
Salvador, 41810-011
BrazilActive - Recruiting
Fundacao do ABC Centro Universitario FMABC
Santo Andre, 09060 870
BrazilActive - Recruiting
Fundacao Antonio Prudente A C Camargo Cancer Center
Sao Paulo, 01509 900
BrazilActive - Recruiting
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
Sao Paulo, 01246-000
BrazilActive - Recruiting
Irmandade Da Santa Casa De Misericordia De Sao Paulo
Sao Paulo, 01221-020
BrazilActive - Recruiting
Real e Benemérita Associação Portuguesa de Beneficência
Sao Paulo, 01323 900
BrazilActive - Recruiting
Beijing Friendship Hospital Capital Medical University
Beijing, 100050
ChinaActive - Recruiting
Peking University Third Hospital
Beijing, 100191
ChinaActive - Recruiting
Hunan Cancer hospital
Changsha, 410013
ChinaActive - Recruiting
The Third People's Hospital of Chengdu
Cheng Du Shi, 610014
ChinaActive - Recruiting
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, 610041
ChinaActive - Recruiting
Chongqing Cancer Hospital
Chong Qing, 400033
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fu Zhou Shi, 350001
ChinaActive - Recruiting
Sun Yat-Sen University Cancer Center
Guang Zhou Shi, 510060
ChinaActive - Recruiting
Nanjing Drum Tower Hospital
Nan Jing Shi, 210008
ChinaActive - Recruiting
Zhongda Hospital Southeast University
Nan Jing Shi, 210009
ChinaActive - Recruiting
Huadong Hospital Affiliated to Fudan University
Shanghai, 200031
ChinaActive - Recruiting
The Second Hospital Of Tianjin Medical University
Tianjin, 300061
ChinaActive - Recruiting
Cancer Hospital of Xinjiang Medical University
Urumqi, 830011
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
ChinaActive - Recruiting
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wu Han Shi, 430032
ChinaActive - Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wu Han Shi, 430032
ChinaActive - Recruiting
The First Affiliated Hospital of Xian Jiaotong University
XI An Shi, 710063
ChinaActive - Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221004
ChinaActive - Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Kralove, 500 05
CzechiaActive - Recruiting
Krajská nemocnice Liberec a.s.
Liberec, 460 63
CzechiaSite Not Available
Fakultni nemocnice Olomouc
Olomouc, 779 00
CzechiaActive - Recruiting
Fakultni nemocnice v Motole
Praha, 150 06
CzechiaActive - Recruiting
Vseobecna fakultni nemocnice v Praze
Praha 2, 128 08
CzechiaActive - Recruiting
Fakultni Thomayerova nemocnice
Praha 4, 140 59
CzechiaActive - Recruiting
Aarhus University Hospital
Aarhus, 8200
DenmarkActive - Recruiting
Herlev Hospital
Herlev, 2730
DenmarkActive - Recruiting
Rigshospitalet
Kobenhavn, 2100
DenmarkActive - Recruiting
Odense Universitetshospital
Odense, 5000
DenmarkActive - Recruiting
Zealand University Hospital
Roskilde, 4000
DenmarkActive - Recruiting
Hospital Center University De Lille
Lille, 59000
FranceActive - Recruiting
Polyclinique de Limoges - Francois Chenieux
Limoges, 87000
FranceActive - Recruiting
Hôpital Edouard Herriot
Lyon, 69003
FranceActive - Recruiting
Institut Paoli Calmettes
Marseille, 13009
FranceActive - Recruiting
APHP - Hopital Bichat - Claude Bernard
Paris, 75018
FranceActive - Recruiting
CHU Pitie Salpetriere
Paris, 75013
FranceActive - Recruiting
Hopital Saint Louis
Paris, 75010
FranceActive - Recruiting
Clinique de la Croix du Sud
Quint-Fonsegrives, 31130
FranceActive - Recruiting
Chu Rennes Hopital Pontchaillou
Rennes, 35000
FranceActive - Recruiting
CHU Rangueil
Toulouse, 31059
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Charite - Universitaetsmedizin Berlin (CCM)
Berlin, 10117
GermanyActive - Recruiting
Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
Braunschweig, 38126
GermanyActive - Recruiting
Urologische Gemeinschaftspraxis
Dresden, 01307
GermanyActive - Recruiting
Universitaetsklinikum Frankfurt
Frankfurt am Main, 60596
GermanyActive - Recruiting
Urologikum Hamburg MVZ - Germany
Hamburg, 22081
GermanyActive - Recruiting
Marien hospital Herne
Herne, 44625
GermanyActive - Recruiting
Universitatsklinikum Jena
Jena, 07747
GermanyActive - Recruiting
Studienzentrum Bayenthal
Koeln, 50968
GermanyActive - Recruiting
Klinikum rechts der Isar an der Technischen Universitat Munchen
Munchen, 81675
GermanyActive - Recruiting
Klinikum St. Elisabeth Straubing GmbH
Straubing, 94315
GermanyActive - Recruiting
Katharinenhospital Innere Medizin
Stuttgart, 70174
GermanyActive - Recruiting
Prince Of Wales Hospital
Hong Kong,
Hong KongActive - Recruiting
Queen Mary Hospital
Hong Kong,
Hong KongActive - Recruiting
Cork University Hospital
Cork, T12 DC4A
IrelandActive - Recruiting
Adelaide and Meath Hospital
Dublin, D24 NR0A
IrelandActive - Recruiting
Mater Misericordiae University Hospital
Dublin, D07 A8NN
IrelandActive - Recruiting
Mater Private Hospital
Dublin, D07 WKW8
IrelandActive - Recruiting
Rambam Health Care Campus
Haifa, 3109601
IsraelActive - Recruiting
Hadassah University Hospita - Ein Kerem
Jerusalem, 9112001
IsraelActive - Recruiting
Hadassah University Hospita Ein Kerem
Jerusalem, 9112001
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, 5262000
IsraelActive - Recruiting
Ziv Medical Center
Safed, 13100
IsraelActive - Recruiting
Sourasky Medical Center
Tel-Aviv, 6423906
IsraelActive - Recruiting
Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica
Arezzo, 52100
ItalyActive - Recruiting
Cliniche Humanitas Gavazzeni
Bergamo, 24125
ItalyActive - Recruiting
ASST Spedali Civili Brescia
Brescia, 25123
ItalyActive - Recruiting
Istituto Dei Tumori Di Milano
Milano, 20133
ItalyActive - Recruiting
Ospedale San Raffaele
Milano, 20132
ItalyActive - Recruiting
Istituto Nazionale Tumori Regina Elena
Roma, 00144
ItalyActive - Recruiting
Universita Campus Bio-Medico di Roma
Roma, 00128
ItalyActive - Recruiting
Istituto Clinico Humanitas
Rozzano, 20089
ItalyActive - Recruiting
A.O.Citta della Salute e della Scienza di Torino
Torino, 10126
ItalyActive - Recruiting
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki shi, 660 8550
JapanActive - Recruiting
St Marianna University Hospital
Kawasaki Shi, 216 8511
JapanActive - Recruiting
Kobe City Medical Center General Hospital
Kobe City, 650 0047
JapanActive - Recruiting
National Hospital Organization Kumamoto Medical Center
Kumamoto City, 860 0008
JapanActive - Recruiting
Osaka International Cancer Institute
Osaka, 541 8567
JapanActive - Recruiting
Gunma Prefectural Cancer Center
Ota, 373 8550
JapanActive - Recruiting
Saitama Medical Center
Saitama, 350 8550
JapanActive - Recruiting
JRC Wakayama Medical Center
Wakayama, 640 8558
JapanActive - Recruiting
Yokohama City University Medical Center
Yokohama, 232 0024
JapanActive - Recruiting
Yokohama Municipal Citizen's Hospital
Yokohama, 221 0855
JapanActive - Recruiting
Yokohama Municipal Citizens Hospital
Yokohama, 221 0855
JapanActive - Recruiting
Yokosuka Kyosai Hospital
Yokosuka, 238 8558
JapanActive - Recruiting
Chungbuk National University Hospital
Chungcheongbuk Do, 28644
Korea, Republic ofActive - Recruiting
National Cancer Center
Gyeonggi-do, 10408
Korea, Republic ofActive - Recruiting
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 3080
Korea, Republic ofActive - Recruiting
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Korea, Republic ofActive - Recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15 276
PolandActive - Recruiting
Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
Bydgoszcz, 85 796
PolandActive - Recruiting
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, 85 796
PolandActive - Recruiting
IN VIVO Sp. z o.o
Bydgoszcz, 85 048
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny nr 4
Lublin, 20 090
PolandActive - Recruiting
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemysl, 37 700
PolandActive - Recruiting
Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
Tarnow, 33-100
PolandActive - Recruiting
Medicover Integrated Clinical Services Sp z o o
Torun, 87-100
PolandActive - Recruiting
Mazowiecki Szpital Onkologiczny Sp z o o
Wieliszew, 05-135
PolandActive - Recruiting
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Wroclaw, 50 981
PolandActive - Recruiting
Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii
Wroclaw, 53-413
PolandActive - Recruiting
Hosp Univ A Coruna
A Coruna, 15006
SpainActive - Recruiting
Hosp. Univ. de La Ribera
Alzira, 46600
SpainActive - Recruiting
Fund. Puigvert
Barcelona, 08025
SpainActive - Recruiting
Hosp Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Hosp. Puerta Del Mar
Cadiz, 11009
SpainActive - Recruiting
Hosp. Gral. Univ. de Castellon
Castellon, 12004
SpainActive - Recruiting
Hosp. de Jerez de La Frontera
Jerez De La Frontera, 11407
SpainActive - Recruiting
Clinica Univ. de Navarra
Madrid, 28027
SpainActive - Recruiting
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
SpainActive - Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hosp Virgen de La Victoria
Malaga, 29010
SpainActive - Recruiting
Hosp. Univ. Central de Asturias
Oviedo, 33011
SpainActive - Recruiting
Hosp.Univ.Parc Tauli
Sabadell, 08208
SpainActive - Recruiting
Hosp. Virgen Del Rocio
Sevilla, 41013
SpainActive - Recruiting
Hosp. Clinico Univ. de Valencia
Valencia, 46010
SpainActive - Recruiting
Adana Baskent Practice and Research Hospital
Adana, 01120
TurkeyActive - Recruiting
Ankara University Medical Faculty
Ankara, 06100
TurkeyActive - Recruiting
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200
TurkeyActive - Recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34153
TurkeyActive - Recruiting
Kartal Dr Lutfi Kirdar sehir Hastanesi
Istanbul, 34865
TurkeyActive - Recruiting
T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
Istanbul, 34722
TurkeyActive - Recruiting
Dokuz Eylul University Medical Faculty
Izmir, 35330
TurkeyActive - Recruiting
Southmead Hospital
Bristol, BS105NB
United KingdomActive - Recruiting
Charing Cross Hospital
London, W6 8RF
United KingdomActive - Recruiting
St Bartholomews Hospital
London, EC1A 7BE
United KingdomActive - Recruiting
Newcastle Freeman Hospital
Newcastle Upon Tyne, NE7 7DN
United KingdomActive - Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2SJ
United KingdomActive - Recruiting
Southampton General Hospital
Southampton, SO16 6YD
United KingdomActive - Recruiting
Royal Marsden Hospital
Sutton, SM2 5PT
United KingdomActive - Recruiting
Arkansas Urology
Little Rock, Arkansas 72211
United StatesActive - Recruiting
Genesis Research LLC
Los Alamitos, California 90720
United StatesActive - Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesActive - Recruiting
University of California Irvine Medical Center
Orange, California 92868
United StatesActive - Recruiting
Genesis Research
San Diego, California 92123
United StatesActive - Recruiting
Genesis Research LLC
Sherman Oaks, California 91411
United StatesActive - Recruiting
University of Colorado Cancer Center Anschultz Cancer Pavilion
Aurora, Colorado 80045
United StatesActive - Recruiting
Colorado Clinical Research
Lakewood, Colorado 80228
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
First Urology
Jeffersonville, Indiana 47130
United StatesActive - Recruiting
Wichita Urology Group
Wichita, Kansas 67226
United StatesActive - Recruiting
Ochsner Health System
New Orleans, Louisiana 70121-2429
United StatesActive - Recruiting
Chesapeake Urology Research Associates
Hanover, Maryland 21076
United StatesCompleted
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Comprehensive Urology
Royal Oak, Michigan 48073
United StatesActive - Recruiting
Mercy Research
Saint Louis, Missouri 63141
United StatesActive - Recruiting
Specialty Clinical Research of St Louis
Saint Louis, Missouri 63141
United StatesActive - Recruiting
The Urology Center, PC
Omaha, Nebraska 68114
United StatesActive - Recruiting
Cancer Institute Of New Jersey
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Integrated Medical Professionals
New York, New York 10016
United StatesActive - Recruiting
Associated Medical Professionals of Ny
Syracuse, New York 13210
United StatesActive - Recruiting
SUNY Upstate Med Univ
Syracuse, New York 13210
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Associated Urologists of North Carolina
Raleigh, North Carolina 27612
United StatesActive - Recruiting
University Hospitals Seidman Cancer Center
Cleveland, Ohio 44106
United StatesSite Not Available
MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
United StatesActive - Recruiting
Keystone Urology Specialists
Lancaster, Pennsylvania 17604
United StatesActive - Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
The Conrad Pearson Clinic
Germantown, Tennessee 38138
United StatesActive - Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesActive - Recruiting
Urology Associates
Nashville, Tennessee 37209
United StatesActive - Recruiting
Urology Austin
Austin, Texas 78745
United StatesActive - Recruiting
Urology Clinics of North Texas
Dallas, Texas 75231
United StatesActive - Recruiting
Houston Metro Urology
Houston, Texas 77027
United StatesActive - Recruiting
Spokane Urology
Spokane, Washington 99202
United StatesActive - Recruiting
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