The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease.
Bladder cancer is the tenth most common malignancy worldwide. The natural history of
high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) is unpredictable; rates of recurrence
vary from 15 percent (%) to 78%, and rates of progression to muscle invasion and metastasis
vary from less than (<) 1 to 45%. The TAR-200/gemcitabine (JNJ-17000139-AAC) product
(hereafter, TAR-200) is an intravesical drug delivery system regulated as an investigational
drug. The drug constituent consists of gemcitabine minitablets, and osmotic minitablets
containing urea as the osmotic agent. Cetrelimab (JNJ-63723283) is a fully human
immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds PD-1. This study consists
3 periods: screening phase (up to 30 days); treatment phase (up to 2 years); follow up phase
(up to 5 years). Total duration of study is up to 5 years. Efficacy, safety, pharmacokinetics
(PK), and biomarkers will be assessed at specified time points during this study.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | December 18, 2020 | Phase 2 | Interventional |
Primary Outcome 1 - Measure: Overall Clinical Response (CR) Rate
Primary Outcome 1 - Time Frame: Up to 5 years
Criteria:
Inclusion Criteria:
- Histologically confirmed diagnosis of high-risk, non-muscle invasive urothelial
carcinoma in situ (CIS; Tis), with or without papillary disease (T1, high-grade Ta)
within 12 months of completion of adequate Bacillus Calmette-Guerin (BCG) therapy.
Mixed histology tumours are allowed if urothelial differentiation (transitional cell
histology) is predominant (example, less than (<) 20 percent (%) variant histologic
subtype). However, the presence of neuroendocrine, micropapillary, signet ring cell,
plasmacytoid, or sarcomatoid features will make a participant ineligible. For
participants with lamina propria invasion (T1) on the screening biopsy/ transurethral
resection of bladder tumor (TURBT), muscularis propria must be present in order to
rule out Muscle Invasive Bladder Cancer (MIBC)
- Visible papillary disease must be fully resected (absent) prior to randomization
(residual CIS acceptable) and documented at screening cystoscopy
- Participants must be ineligible for or have elected not to undergo radical cystectomy
- BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as
a minimum of 5 of 6 doses of an induction course (adequate induction) plus 2 of 3
doses of a maintenance course, or 2 of 6 doses of a second induction course
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
Exclusion Criteria:
- Histologically confirmed, muscle-invasive, locally advanced, nonresectable, or
metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV
- Concurrent extra-vesical (that is, urethra, ureter, or renal pelvis) non-muscle
invasive transitional cell carcinoma of the urothelium
- Participants with an active, known or suspected autoimmune disease. Participants with
autoimmune disorders not requiring systemic treatment (example, skin conditions such
as vitiligo, psoriasis, alopecia) or conditions requiring hormonal replacement
therapies such as type 1 diabetes mellitus or hypothyroidism are permitted to enroll
- Known active hepatitis B or C infection (for example, participants with history of
hepatitis C infection but normal hepatitis C virus polymerase chain reaction test and
participants with hepatitis B with positive hepatitis B surface antigen (HBsAg)
antibody are allowed)
- Prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-ligand 2 (L2)
agent, or with an agent directed to another co-inhibitory T-cell receptor
Show More
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Janssen Research & Development, LLC Clinical Trial
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 | |
Urological Associates of Southern Arizona, P.C. Tucson, Arizona 85715 United States |
Not yet recruiting | |
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 | |
DuPage Medical Group Lisle, Illinois 60532 United States |
Not yet recruiting | |
Indiana University Indianapolis, Indiana 46202-5116 United States |
Withdrawn | |
Johns Hopkins Medical Institutions Baltimore, Maryland 21287 United States |
Not yet recruiting | |
Wayne State University Detroit, Michigan 48202 United States |
Not yet recruiting | |
NYU Langone Health New York, New York 10017 United States |
Not yet recruiting | |
University of Rochester Rochester, New York 14627 United States |
Not yet recruiting | |
SUNY Upstate Medical University Syracuse, New York 13210-2375 United States |
Not yet recruiting | |
Associated Medical Professionals Syracuse, New York 13210 United States |
Not yet recruiting | |
Levine Cancer Institute Charlotte, North Carolina 28204 United States |
Not yet recruiting | |
Oregon Urology Institute Springfield, Oregon 97477 United States |
Withdrawn | |
Urologic Consultants of Southeastern Pennsylvania Bala-Cynwyd, Pennsylvania 19004 United States |
Recruiting | |
Thomas Jefferson University Philadelphia, Pennsylvania 19107 United States |
Not yet recruiting | |
Urology Associates, PC Nashville, Tennessee 37209 United States |
Recruiting | |
Vanderbilt University Medical Center Nashville, Tennessee 37232 United States |
Not yet recruiting | |
University of Texas Southwestern Medical Center Dallas, Texas 75390 United States |
Not yet recruiting | |
Urology San Antonio Research San Antonio, Texas 78229 United States |
Not yet recruiting | |
Spokane Urology Spokane, Washington 99202 United States |
Not yet recruiting | |
Flinders Medical Centre Bedford Park, 5042 Australia |
Not yet recruiting | |
Eastern Health Research Box Hill, 3128 Australia |
Not yet recruiting | |
Prince Of Wales Hospital Randwick, 2031 Australia |
Not yet recruiting | |
Royal North Shore Hospital St Leonards, 2065 Australia |
Not yet recruiting | |
Macquarie University Hospital Sydney, 2109 Australia |
Not yet recruiting | |
Princess Alexandra Hospital Woolloongabba, 4102 Australia |
Not yet recruiting | |
AZ St.-Jan Brugge-Oostende AV Brugge, 8000 Belgium |
Not yet recruiting | |
Hopital Erasme Brussel, 1070 Belgium |
Not yet recruiting | |
Universitair Ziekenhuis Gent Gent, 9000 Belgium |
Not yet recruiting | |
Algemeen Ziekenhuis Delta Roeselare, 8800 Belgium |
Not yet recruiting | |
AZ Nikolaas Sint-Niklaas, 9100 Belgium |
Not yet recruiting | |
Exdeo Clinical Research Inc Abbotsford, British Columbia V2S 3N5 Canada |
Not yet recruiting | |
The Male/Female Health and Research Centre Barrie, Ontario L4M 7G1 Canada |
Not yet recruiting | |
Princess Margaret Hospital- UHN Toronto, Ontario M5G 2M9 Canada |
Not yet recruiting | |
McGill University Health Centre Montreal, Quebec H4A 3J1 Canada |
Not yet recruiting | |
Universite de Sherbrooke Sherbrooke, Quebec J1H 5H3 Canada |
Not yet recruiting | |
Polyclinique Bordeaux Nord Acquitaine Bordeaux, 33300 France |
Not yet recruiting | |
CHU Grenoble Grenoble, 38043 France |
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, 13273 France |
Not yet recruiting | |
CHU Nîmes Nimes, 30029 France |
Not yet recruiting | |
Hôpital Universitaire Pitié-Salpêtrière Paris Cedex 13, 75013 France |
Not yet recruiting | |
Hopital Europeen Georges-Pompidou Paris, 75015 France |
Not yet recruiting | |
Groupe Hospitalier Diaconesses Croix Saint Simon Paris, 75020 France |
Not yet recruiting | |
Hopital Bichat Claude Bernard Paris, 75877 France |
Not yet recruiting | |
CHU De Poitiers Poitiers, 86021 France |
Withdrawn | |
Hopital Pontchaillou Rennes cedex 9, 35033 France |
Not yet recruiting | |
CHP Saint Gregoire Saint Gregoire, 35760 France |
Not yet recruiting | |
Institut de Cancérologie Strasbourg Europe (ICANS) Strasbourg, 67200 France |
Not yet recruiting | |
Hopital Foch Suresnes, 92151 France |
Not yet recruiting | |
Urologicum Duisburg Duisburg, 47179 Germany |
Not yet recruiting | |
Klinikum Herne - Urologie Herne, 44625 Germany |
Not yet recruiting | |
Uniklinik Köln Köln, 50937 Germany |
Not yet recruiting | |
Urologische Partnerschaft Köln UPK Köln, 50968 Germany |
Not yet recruiting | |
Matthias Schulze - Germany Markkleeberg, 04416 Germany |
Not yet recruiting | |
Urologie Neandertal Praxis Mettmann Mettmann, 40822 Germany |
Not yet recruiting | |
Universitätsklinikum Münster Münster, 48149 Germany |
Not yet recruiting | |
Schön Klinik Nürnberg Fürth Nürnberg, 90491 Germany |
Not yet recruiting | |
Studienpraxis Urologie Nürtingen - Germany Nürtingen, 72622 Germany |
Not yet recruiting | |
Kliniken Nordoberpfalz AG/Klinikum Weiden Weiden, 92637 Germany |
Withdrawn | |
Urologische Praxis am Wasserturm - Germany Würselen, 52146 Germany |
Not yet recruiting | |
Attikon University General Hospital of Attica Athens, 12462 Greece |
Withdrawn | |
Metropolitan General A.E. Holargos, 155 62 Greece |
Not yet recruiting | |
Athens Medical Center Maroussi, 151 25 Greece |
Not yet recruiting | |
Bioclinic - Thessaloniki Thessaloniki, 546 22 Greece |
Not yet recruiting | |
General Hospital of Thessaloniki G. Gennimatas Thessaloniki, 54635 Greece |
Not yet recruiting | |
Euromedica General Clinic Thessaloniki, 54645 Greece |
Not yet recruiting | |
'Papageorgiou' General Hospital of Thessaloniki Thessaloniki, TK 56403 Greece |
Not yet recruiting | |
Policlinico Abano Terme Abano Terme, 35031 Italy |
Withdrawn | |
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari, 70120 Italy |
Not yet recruiting | |
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari, 70124 Italy |
Not yet recruiting | |
Azienda Ospedaliera Universitaria Careggi Firenze, 50135 Italy |
Not yet recruiting | |
Ospedale San Martino Genova, 16132 Italy |
Not yet recruiting | |
Ospedale San Raffaele Milan, 20132 Italy |
Not yet recruiting | |
Azienda Ospedaliero Universitaria Pisana Pisa, 56126 Italy |
Not yet recruiting | |
Azienda Ospedaliera Sant Andrea Roma, 00189 Italy |
Not yet recruiting | |
Istituto Nazionale Tumori Regina Elena Rome, 00144 Italy |
Not yet recruiting | |
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino, 10126 Italy |
Not yet recruiting | |
Ospedale di Circolo e Fondazione Macchi Varese, 21100 Italy |
Not yet recruiting | |
Ospedale San Bortolo Vicenza, 36100 Italy |
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 | |
Kimitsu Chuo Hospital Kisarazu, 292-8535 Japan |
Not yet recruiting | |
Nagasaki University Hospital Nagasaki, 852-8501 Japan |
Not yet recruiting | |
JOHAS Osaka Rosai Hospital Osaka, 591-8025 Japan |
Not yet recruiting | |
Toranomon Hospital Tokyo, 105-8470 Japan |
Not yet recruiting | |
Toyama University Hospital Toyama-shi, 930-0194 Japan |
Not yet recruiting | |
Fujita Health University Hospital Toyoake, 470-1192 Japan |
Not yet recruiting | |
University of Tsukuba Hospital Tsukuba-Shi, 305-8520 Japan |
Not yet recruiting | |
Yamaguchi University Hospital Ube, 755-8505 Japan |
Withdrawn | |
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 | |
Chonnam National University Hospital Gwangju, 61469 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 | |
Noordwest Ziekenhuisgroep Alkmaar, 1800 AM Netherlands |
Not yet recruiting | |
Catharina Ziekenhuis Eindhoven, 5623EJ Netherlands |
Not yet recruiting | |
Canisius-Wilhelmina Ziekenhuis Nijmegen, 6532SZ Netherlands |
Not yet recruiting | |
The Julius Center - Utrecht Science Park - Stratenum Utrecht, 3508 GA Netherlands |
Not yet recruiting | |
Hospital Garcia de Orta Almada, 2805-267 Portugal |
Not yet recruiting | |
Hospital da Senhora da Oliveira Guimarães, 4835-044 Portugal |
Not yet recruiting | |
Centro Hospitalar de Lisboa Central Lisboa, 1150-199 Portugal |
Not yet recruiting | |
Fundação Champalimaud Lisbon, 1400-038 Portugal |
Not yet recruiting | |
Hospital Beatriz Angelo Loures, 2674-514 Portugal |
Not yet recruiting | |
Instituto Portugues de Oncologia do Porto Francisco Gentil Porto, 4200-072 Portugal |
Not yet recruiting | |
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. Vila Nova de Gaia, 4434-502 Portugal |
Not yet recruiting | |
Centro Hospitalar de Trás os Montes e Alto-Douro Vila Real, 5000508 Portugal |
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 | |
City Clinical Hospital #1 Nizhny Novgorod, 603109 Russian Federation |
Not yet recruiting | |
Avicenna Medical Center Novosibirsk, 630099 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 | |
Ultrasound Clinic 4D Pyatigorsk, 357502 Russian Federation |
Not yet recruiting | |
Hospital for War Veterans Rostov-on-Don, 344037 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 | |
Saratov State Medical University Saratov, 410054 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. Clinic I Provincial de Barcelona Barcelona, 08036 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 | |
Hosp. Univ. Ramon Y Cajal Madrid, 28034 Spain |
Not yet recruiting | |
Hosp. Univ. 12 de Octubre Madrid, 28041 Spain |
Not yet recruiting | |
Hosp. Univ. 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 | |
Corporacio Sanitari Parc Tauli Sabadell, 08208 Spain |
Not yet recruiting | |
Instituto Valenciano de Oncologia Valencia, 46009 Spain |
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, 06590 Turkey |
Not yet recruiting | |
Trakya University Medical Faculty Edirne, 22130 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, 44000 Turkey |
Not yet recruiting | |
Cherkassy Regional Oncology Dispensary, Department of Hematology Cherkasy, 18009 Ukraine |
Not yet recruiting | |
Chernihivskyi oblasnyi onkolohichnyi dyspanser Chernihiv, 14029 Ukraine |
Not yet recruiting | |
Chernivtsi Regional Clinical Hospital Chernivtsi, 58000 Ukraine |
Not yet recruiting | |
SE Dnipropetrovsk Medical Academy Dnipro, 49005 Ukraine |
Not yet recruiting | |
Main Military Clinical Hospital of MDU Kiev, 01133 Ukraine |
Not yet recruiting | |
Asklepion LLC Kiev, 08173 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 | |
Lviv Regional Clinical Hospital Lviv, 79000 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 | |
NHS Greater Glasgow and Clyde Glasgow, G12 0YN United Kingdom |
Not yet recruiting | |
East and North Hertfordshire NHS Trust Hertfordshire, SG1 4AB United Kingdom |
Not yet recruiting | |
Leeds Teaching Hospitals NHS Trust Leeds, LS9 7TF United Kingdom |
Not yet recruiting | |
Guys' and St Thomas' NHS Trust London, SE1 9RT United Kingdom |
Not yet recruiting | |
The Christie Nhs Foundation Trust Manchester, M20 4BX United Kingdom |
Not yet recruiting | |
Oxford University Hospitals NHS Foundation Trust Oxford, OX3 7LE United Kingdom |
Not yet recruiting | |
Sheffield Teaching Hospitals NHS Foundation Trust Sheffield, S10 2 JF United Kingdom |
Not yet recruiting |