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BRIEF TITLE: TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy


  • Org Study ID: CR108917
  • Secondary ID: 2020-002620-36,17000139BLC3001
  • NCT ID: NCT04658862
  • NCT Alias:
  • Sponsor: Janssen Research & Development, LLC - Industry
  • Source: Janssen Research & Development, LLC

Brief Summary

The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy.

Detailed Description


TAR-200 is a gemcitabine intravesical delivery system that provides a continuous release of
gemcitabine into the urine. Urothelial carcinoma, specifically transitional cell carcinoma of
the upper and lower genitourinary tract, has demonstrated meaningful responsiveness to
deoxycytidine analogues. Gemcitabine has also demonstrated efficacy and a tolerable safety
profile in NMIBC and metastatic urothelial carcinoma. Study consists of screening phase of 42
days, treatment phase and follow up phase. The total duration of study will be up to 8 years.
Efficacy evaluation includes disease assessment (Cystoscopy/TURBT Biopsy/Pathology) and
Patient Reported Outcomes (Quality of Life Assessments) and safety assessments includes vital
sign measurements, 12-lead electrocardiogram (ECG), physical examinations, clinical
laboratory tests, cystoscopic examination, anti-drug antibody (ADA) assessments, concomitant
treatments/procedures and adverse event monitoring.

Overal Status Start Date Phase Study Type
Recruiting December 7, 2020 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event

Primary Outcome 1 - Time Frame: Up to 8 years

Condition:

  • Urinary Bladder Neoplasms

Eligibility

Criteria:
Inclusion Criteria:

- Ineligible for or have elected not to undergo radical cystectomy

- All adverse events associated with any prior surgery and/or intravesical therapy must
have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Grade less than (<) 2 prior to randomization

- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

- Thyroid function tests within normal range or stable on hormone supplementation per
investigator assessment.

- Adequate bone marrow, liver, and renal function: Bone marrow function (without the
support of cytokines or erythropoiesis-stimulating agent in preceding two weeks):
Absolute neutrophil count (ANC) greater than or equal to (>=) 1,000/cubic millimeters
(mm^3); Platelet count >=75,000/mm^3; Hemoglobin >=8.0 grams per deciliter (g/dL);
Liver function: (Total bilirubin less than or equal to (<=) 1.5 * upper limit of
normal (ULN) or direct bilirubin <= ULN for participants with total bilirubin levels
greater than (>)1.5*ULN (except participants with Gilbert's Syndrome, who must have a
total bilirubin < 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) less than or equal to (<=) 2.5* institutional ULN); Renal
function: Creatinine clearance >40 mL/min either directly measured via 24-hour urine
collection, calculation using the Cockcroft-Gault formula, or calculation for the
modification of diet in renal disease for adult participants

Exclusion Criteria:

- Must not have had urothelial carcinoma or histological variant at any site outside of
the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract
(including renal pelvis and ureter) is allowable if treated with complete
nephrouretrectomy within 24 months

- Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS
is defined as the presence of at least 4 distinct CIS lesions in the bladder at the
time of the Screening re-TURBT

- Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local
radiology staging (chest, abdomen, and pelvis must be performed using Computed
tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to
randomization

- 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

- Evidence of bladder perforation during diagnostic cystoscopy
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Janssen Research & Development, LLC Clinical Trials

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Study Contact

Phone: 844-434-4210

Email: JNJ.CT@sylogent.com

Link: To learn how to participate in this trial please click here.

Locations

Facility Status Contact
Bladder Cancer Genitourinary Oncology
Phoenix, Arizona 85032
United States
Withdrawn
University of Southern California
Los Angeles, California 90033
United States
Not yet recruiting
The Urology Center of Colorado
Denver, Colorado 80211
United States
Not yet recruiting
Foothills Urology - Golden Off
Golden, Colorado 80401
United States
Not yet recruiting
UF Health Jacksonville
Jacksonville, Florida 32209
United States
Not yet recruiting
The University Of Chicago Medicine
Chicago, Illinois 60637
United States
Not yet recruiting
DuPage Medical Group
Lisle, Illinois 60532
United States
Not yet recruiting
Johns Hopkins Medical Institutions
Baltimore, Maryland 21287
United States
Not yet recruiting
Adult Pediatric Urology & Urogynecology, P.C
Omaha, Nebraska 68114
United States
Withdrawn
NYU Langone Health
New York, New York 10017
United States
Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Not yet recruiting
Columbia University Medical Center, Herbert Irving Pavilliion
New York, New York 10032
United States
Withdrawn
Associated Medical Professionals
Syracuse, New York 13210
United States
Not yet recruiting
Ohio State University
Columbus, Ohio 43210
United States
Not yet recruiting
Oregon Urology Institute
Springfield, Oregon 97477
United States
Not yet recruiting
Urologic Consultants of Southeastern PA
Bala-Cynwyd, Pennsylvania 19004
United States
Not yet recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Withdrawn
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Recruiting
Urology Associates, PC
Nashville, Tennessee 37209
United States
Withdrawn
University of Texas Medical Branch
League City, Texas 77573
United States
Not yet recruiting
Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Not yet recruiting
Spokane Urology
Spokane, Washington 99202
United States
Not yet recruiting
Centro Urologico Profesor Bengio
Córdoba, X5000KPH
Argentina
Not yet recruiting
Centro Oncologico Riojano Integral (Cori)
La Rioja, F5300COE
Argentina
Not yet recruiting
Flinders Medical Centre
Bedford Park, 5042
Australia
Not yet recruiting
Royal North Shore Hospital
St Leonards, 2065
Australia
Not yet recruiting
Fundacao Pio Xii - Hospital De Cancer De Barretos
Barretos, 14784
Brazil
Not yet recruiting
Fundação Hospitalar São Francisco de Assis
Belo Horizonte, 31110-580
Brazil
Not yet recruiting
Centro de Pesquisa Urologica e Oncologia de Campinas
Campinas, 13073-400
Brazil
Suspended
Hospital Erasto Gaertner
Curitiba, 81520-060
Brazil
Not yet recruiting
Centro de Pesquisas Oncológicas - CEPON
Florianópolis, 88034-000
Brazil
Not yet recruiting
Centro Regional Integrado de Oncologia - Crio
Fortaleza, 60336-045
Brazil
Not yet recruiting
Hospital de Caridade de Ijui
Ijuí, 98700-000
Brazil
Not yet recruiting
Clinica de Oncologia Reichow
Jardim Blumenau, 89010-340
Brazil
Not yet recruiting
Hospital Amaral Carvalho
Jaú, 17210-180
Brazil
Not yet recruiting
Liga Norte Riograndense Contra O Cancer
Natal, 59062-000
Brazil
Not yet recruiting
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903
Brazil
Suspended
Hospital São Lucas - PUCRS
Porto Alegre, 90610-000
Brazil
Not yet recruiting
Hospital Sao Rafael
Salvador, 41253-190
Brazil
Not yet recruiting
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, 09060-650
Brazil
Not yet recruiting
ICESP - Instituto do Câncer do Estado de São Paulo
Sao Paolo, 01246
Brazil
Not yet recruiting
Hospital Sirio Libanes
Sao Paulo, 04784180
Brazil
Not yet recruiting
Fundação Faculdade de Medicina de São José Do Rio Preto
São José Do Rio Preto, 15090000
Brazil
Not yet recruiting
Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO
São Paulo, 04039-004
Brazil
Not yet recruiting
Centro Oncológico do Triângulo
Uberlândia, 38408-150
Brazil
Not yet recruiting
Vancouver General Hospital
Vancouver, British Columbia V6H 3Z6
Canada
Withdrawn
The Male/Female Health and Research Centre
Barrie, Ontario L4M 7G1
Canada
Not yet recruiting
University of Toronto
Toronto, Ontario M5G 2M9
Canada
Not yet recruiting
McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada
Not yet recruiting
CHU de Québec -L'Hôtel-Dieu de Québec
Québec, Quebec G1R 2J6
Canada
Not yet recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec J1H 5H3
Canada
Not yet recruiting
Kromerizska nemocnice a.s.
Kromeriz, 767 01
Czechia
Not yet recruiting
Slezska nemocnice v Opave
Opava, 746 01
Czechia
Not yet recruiting
Urocentrum Praha
Praha 2, 120 00
Czechia
Not yet recruiting
Thomayerova nemocnice
Praha 4, 140 59
Czechia
Not yet recruiting
Fakultni nemocnice v Motole
Praha 5, 150 06
Czechia
Not yet recruiting
Androgeos S.R.O.
Praha 6, 160 00
Czechia
Suspended
Fakultni nemocnice Kralovske Vinohrady
Praha, 100 34
Czechia
Not yet recruiting
Eticka komise Krajska Nemocnice Tomase Bati
Zlin, 76275
Czechia
Not yet recruiting
Clinique Sainte Marguerite
Hyeres, 83400
France
Not yet recruiting
Polyclinique de Limoges - Francois Chenieux
Limoges, 87000
France
Not yet recruiting
Hôpital Edouard Herriot
Lyon Cedex 03, 69437
France
Not yet recruiting
Institut Paoli-Calmettes
Marseille, 13009
France
Not yet recruiting
Institut Regional du Cancer de Montpellier
Montpellier, 34298
France
Not yet recruiting
CHU Nîmes
Nimes, 30029
France
Not yet recruiting
Hopital Europeen Georges-Pompidou
Paris, 75015
France
Not yet recruiting
Hôpital Bichat - Claude Bernard
Paris, 75018
France
Not yet recruiting
CHU De Poitiers
Poitiers, 86021
France
Withdrawn
Centre Hospitalier Prive
Saint-Grégoire, 35760
France
Not yet recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse Cedex 9, 31059
France
Not yet recruiting
Urologicum Duisburg
Duisburg, 47179
Germany
Not yet recruiting
Universitätsklinikum Düsseldorf
Düesseldorf, 40225
Germany
Not yet recruiting
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
Frankfurt Am Main, 60431
Germany
Not yet recruiting
Universitatsklinikum Frankfurt
Frankfurt am Main, 60590
Germany
Not yet recruiting
Klinikum Herne - Urologie
Herne, 44625
Germany
Not yet recruiting
Matthias Schulze - Germany
Markkleeberg, 04416
Germany
Not yet recruiting
Universitätsklinikum Münster
Münster, 48149
Germany
Not yet recruiting
Klinikum Nürnberg Nord - Hautklinik
Nürnberg, 90419
Germany
Not yet recruiting
Kliniken Nordoberpfalz AG/Klinikum Weiden
Weiden, 92637
Germany
Not yet recruiting
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1204
Hungary
Not yet recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Hungary
Not yet recruiting
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400
Hungary
Not yet recruiting
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5004
Hungary
Not yet recruiting
Hillel Yaffe Medical Center
Hadera, 3810101
Israel
Not yet recruiting
Rambam Health Care Campus
Haifa, 3109601
Israel
Not yet recruiting
Hadassah University Hospita - Ein Kerem
Jerusalem, 9112001
Israel
Not yet recruiting
Ziv Medical Center
Safed, 13100
Israel
Not yet recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Israel
Not yet recruiting
Iizuka Hospital
Iizuka, 820-8501
Japan
Not yet recruiting
St.Marianna University School of Medicine
Kanagawa, 216-8511
Japan
Not yet recruiting
Nara Medical University Hospital
Kashihara, 634-8522
Japan
Not yet recruiting
Saitama Medical University Hospital
Kawagoe-Shi, 350-8550
Japan
Not yet recruiting
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008
Japan
Suspended
Nagasaki University Hospital
Nagasaki, 852-8501
Japan
Not yet recruiting
JOHAS Osaka Rosai Hospital
Osaka, 591-8025
Japan
Not yet recruiting
Sagamihara Kyodo Hospital
Sagamihara-Shi, 252-0253
Japan
Not yet recruiting
Tokuyama Central Hospital
Shunan, 745-8522
Japan
Not yet recruiting
Toranomon Hospital
Tokyo, 105-8470
Japan
Not yet recruiting
Fujita Health University Hospital
Toyoake, 470-1192
Japan
Not yet recruiting
Yamaguchi University Hospital
Ube, 755-8505
Japan
Not yet recruiting
Yokohama City University Medical Center
Yokohama, 232-0024
Japan
Not yet recruiting
Inje University Haeundae Paik Hospital
Busan, 612-896
Korea, Republic of
Not yet recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic of
Not yet recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
Korea, Republic of
Not yet recruiting
National Cancer Center
Goyang-si, 10408
Korea, Republic of
Not yet recruiting
Gachon University Gil Medical Center
Namdong, 405 760
Korea, Republic of
Not yet recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Not yet recruiting
Severance Hospital
Seoul, 03722
Korea, Republic of
Not yet recruiting
Gangnam Severance Hospital
Seoul, 06273
Korea, Republic of
Not yet recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic of
Not yet recruiting
Pusan National University Yangsan Hospital
Yangsan-si, 50612
Korea, Republic of
Not yet recruiting
CRYPTEX Investigacion clinica S.A De C.V
Ciudad de México, 06100
Mexico
Not yet recruiting
Oncología Integral Satelite
Ciudad de México, 06720
Mexico
Not yet recruiting
Consultorio Privado Dr Jose Arturo Rodriguez Rivera
Guadalajara, 45050
Mexico
Not yet recruiting
Centro De Estudio Y Prevencion Del Cancer
Juchitan De Zaragoza, 70000
Mexico
Not yet recruiting
Dr. Marco Antonio Badillo Santoyo
Leon, 37000
Mexico
Not yet recruiting
i Can Oncology Center
Monterrey, 64710
Mexico
Not yet recruiting
Oncológico Potosino
San Luis Potosi, 78250
Mexico
Not yet recruiting
Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.
Zapopan, 45070
Mexico
Not yet recruiting
Altlay Regional Oncology Dispensary
Barnaul, 656045
Russian Federation
Not yet recruiting
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
Chelyabinsk, 454087
Russian Federation
Not yet recruiting
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040
Russian Federation
Not yet recruiting
N. N. Blokhin Russian Academy of Medical Sciences
Moscow, 115478
Russian Federation
Not yet recruiting
Hertzen Oncology Research Institute
Moscow, 125284
Russian Federation
Not yet recruiting
A. Tsyb Medical Radiological Research Center
Obninsk, 249031
Russian Federation
Not yet recruiting
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013
Russian Federation
Not yet recruiting
Hospital for War Veterans
Rostov, 344037
Russian Federation
Not yet recruiting
Ryazan State Medical University named after I.P.Pavlov
Ryazan, 390011
Russian Federation
Not yet recruiting
City Multiple-Discipline Hospital # 2
Saint Petersburg, 192174
Russian Federation
Not yet recruiting
FSBHI RSCRST n.a. Ac. Granov A.M. of MoH
Saint Petersburg, 197758
Russian Federation
Not yet recruiting
N.N. Petrov Research Institute Of Oncology
Saint Petersburg, 197758
Russian Federation
Not yet recruiting
Leningrad Regional Oncology Dispensary
Saint-Petersburg, 191104
Russian Federation
Not yet recruiting
Severo-Zapadnyy Gosudarstvennyy Meditsinskiy Universitet Im. I. I. Mechnikova
Sankt-Peterburg, 195067
Russian Federation
Not yet recruiting
Ogarev Mordovian State University
Saransk, 430005
Russian Federation
Not yet recruiting
State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio
Sochi, 354057
Russian Federation
Not yet recruiting
Multifunctional clinical medical center 'Medical city'
Tyumen, 625041
Russian Federation
Not yet recruiting
Bashkir State Medical University
Ufa, 450008
Russian Federation
Not yet recruiting
Hosp. Univ. A Coruña
A Coruña, 15006
Spain
Not yet recruiting
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Spain
Not yet recruiting
Fundacion Puigvert
Barcelona, 08025
Spain
Not yet recruiting
Hosp. Puerta Del Mar
Cadiz, 11009
Spain
Not yet recruiting
Hosp. Univ. Virgen de Las Nieves
Granada, 18014
Spain
Not yet recruiting
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407
Spain
Not yet recruiting
Clinica Univ. de Navarra
Madrid, 28027
Spain
Not yet recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
Spain
Not yet recruiting
Hosp. Univ. de La Paz
Madrid, 28046
Spain
Not yet recruiting
Hosp. Univ. Hm Monteprincipe
Madrid, 28660
Spain
Not yet recruiting
Hosp. Virgen de La Victoria
Málaga, 29010
Spain
Not yet recruiting
Instituto Valenciano de Oncologia
Valencia, 46009
Spain
Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 807
Taiwan
Not yet recruiting
China Medical University Hospital
Taichung, 40447
Taiwan
Not yet recruiting
National Cheng Kung University Hospital
Tainan, 70403
Taiwan
Not yet recruiting
National Taiwan University Hospital
Taipei City, 10048
Taiwan
Not yet recruiting
Tri-Service General Hospital
Taipei, 11490
Taiwan
Not yet recruiting
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, 333
Taiwan
Not yet recruiting
Adana Baskent Yuregir Hospital
Adana,
Turkey
Not yet recruiting
Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
Ankara, 06050
Turkey
Not yet recruiting
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, 06100
Turkey
Not yet recruiting
Dokuz Eylul Universitesi Tip Fakultesi
Balcova, 35330
Turkey
Not yet recruiting
Bezmialem University Medical Faculty
Fatih, 34093
Turkey
Not yet recruiting
Medical Park Gaziantep Hastanesi
Gaziantep, 27584
Turkey
Not yet recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34096
Turkey
Not yet recruiting
Istanbul Medeniyet University Goztepe Training and Research Hospital
Istanbul, 34732
Turkey
Not yet recruiting
Office Of Ahmet Cag Cal, MD
Izmir, 35110
Turkey
Not yet recruiting
Izmir Medical Park Hospital
Izmir, 35530
Turkey
Not yet recruiting
Inonu University Medical Faculty
Malatya, 44280
Turkey
Not yet recruiting
Erciyes Univ MKD Hospital
Melikgazi, 38039
Turkey
Not yet recruiting
T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi
Seyhan, 01330
Turkey
Not yet recruiting
Chernivtsi Regional Clinical Hospital
Chernivtsi, 58000
Ukraine
Not yet recruiting
SE Dnipropetrovsk Medical Academy
Dnipro, 49005
Ukraine
Not yet recruiting
MIH V.I. Shapoval Regional Clinical Centre of Urology and Nephrology
Kharkiv, 61037
Ukraine
Not yet recruiting
Kharkiv Regional Clinical Hospital
Kharkiv, 61070
Ukraine
Not yet recruiting
Main Military Clinical Hospital of MDU
Kiev, 01133
Ukraine
Not yet recruiting
Krivorizhskiy Oncology Dispensary
Kriviy Rih, 50048
Ukraine
Not yet recruiting
Oleksandrivska Clinical Hospital of Kyiv City, Infectional Department #2
Kyiv, 01601
Ukraine
Not yet recruiting
Kyiv City Clinical Hospital #3
Kyiv, 02660
Ukraine
Not yet recruiting
State Institution Academy Of Medical Sciences Of Ukraine
Kyiv, 04053
Ukraine
Not yet recruiting
Odes'ka mis'ka klinichna likarnya №10
Odessa, 65000
Ukraine
Not yet recruiting
Sumy Regional Clinical Oncology Centre
Sumy, 40022
Ukraine
Not yet recruiting