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.
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 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
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
Name: Janssen Research & Development, LLC Clinical Trials
Role: Study Director
Affiliation: Janssen Research & Development, LLC
Name: Study Contact
Phone: 844-434-4210
Email: JNJ.CT@sylogent.com
Link: To learn how to participate in this trial please click here.
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 |