Spots Global Cancer Trial Database for A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
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Trial Identification
Brief Title: A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Official Title: Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Study ID: NCT04640623
Conditions
Study Description
Brief Summary: 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; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Urological Associates of Southern Arizona, P.C., Tucson, Arizona, United States
University of Southern California, Los Angeles, California, United States
Genesis Healthcare Partners - Genesis Research Greater Los Angeles, Sherman Oaks, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
Foothills Urology - Golden Off, Golden, Colorado, United States
DuPage Medical Group, Lisle, Illinois, United States
Urology of Indiana, Greenwood, Indiana, United States
Wichita Urology Group, Wichita, Kansas, United States
Michigan Institute of Urology, Troy, Michigan, United States
NYU Langone Health, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Associated Medical Professionals, Syracuse, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
The Urology Group, Cincinnati, Ohio, United States
Urologic Consultants of Southeastern Pennsylvania, Bala-Cynwyd, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Urology Associates, PC, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Urology Austin, Austin, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Urology San Antonio Research, San Antonio, Texas, United States
Spokane Urology, Spokane, Washington, United States
Flinders Medical Centre, Bedford Park, , Australia
Eastern Health Research, Box Hill, , Australia
Macquarie University Hospital, Sydney, , Australia
Algemeen Ziekenhuis Sint-Jan, Assebroek, , Belgium
AZ St.-Jan Brugge-Oostende AV, Brugge, , Belgium
Hopital Erasme, Brussel, , Belgium
Algemeen ziekenhuis Maria Middelares, Gent, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Algemeen Ziekenhuis Delta, Roeselare, , Belgium
AZ Nikolaas, Sint-Niklaas, , Belgium
Exdeo Clinical Research Inc, Abbotsford, British Columbia, Canada
William Osler Health System, Brampton, Ontario, Canada
Princess Margaret Hospital- UHN, Toronto, Ontario, Canada
McGill University Health Centre, Montreal, Quebec, Canada
Universite de Sherbrooke, Sherbrooke, Quebec, Canada
Hopital Pellegrin CHU Bordeaux, Bordeaux, , France
Polyclinique Bordeaux Nord Acquitaine, Bordeaux, , France
CHU Grenoble, Grenoble, , France
Clinique Sainte Marguerite, Hyeres, , France
Polyclinique de Limoges - Francois Chenieux, Limoges, , France
Hôpital Edouard Herriot, Lyon Cedex 03, , France
Institut Paoli-Calmettes, Marseille, , France
Centre de Cancerologie du Grand Montpellier, Montpellier, , France
CHU Nîmes, Nimes, , France
Hôpital Universitaire Pitié-Salpêtrière, Paris Cedex 13, , France
Hopital Saint Louis, Paris, , France
Hopital Europeen Georges-Pompidou, Paris, , France
Groupe Hospitalier Diaconesses Croix Saint Simon, Paris, , France
Hopital Bichat Claude Bernard, Paris, , France
Clinical La Croix Du Sud - Ramsay Santé, Quint-Fonsegrives, , France
Hopital Pontchaillou, Rennes cedex 9, , France
CHP Saint Gregoire, Saint Gregoire, , France
Institut de Cancerologie Strasbourg Europe ICANS, Strasbourg, , France
Hopital Foch, Suresnes, , France
Hopital Rangueil, Toulouse, , France
Urologicum Duisburg, Duisburg, , Germany
Klinikum Herne - Urologie, Herne, , Germany
Urologische Partnerschaft Koln UPK, Köln, , Germany
Matthias Schulze - Germany, Markkleeberg, , Germany
Urologie Neandertal Praxis Mettmann, Mettmann, , Germany
Universitatsklinikum Munster, Münster, , Germany
Schön Klinik Nürnberg Fürth, Nürnberg, , Germany
Studienpraxis Urologie Nürtingen - Germany, Nürtingen, , Germany
Urologische Praxis am Wasserturm - Germany, Würselen, , Germany
Metropolitan General A.E., Holargos, , Greece
Athens Medical Center, Maroussi, , Greece
Bioclinic - Thessaloniki, Thessaloniki, , Greece
General Hospital of Thessaloniki G. Gennimatas, Thessaloniki, , Greece
Euromedica General Clinic, Thessaloniki, , Greece
'Papageorgiou' General Hospital of Thessaloniki, Thessaloniki, , Greece
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Ospedale San Martino, Genova, , Italy
Ospedale San Raffaele, Milan, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Azienda Ospedaliera Sant Andrea, Roma, , Italy
Istituto Nazionale Tumori Regina Elena, Rome, , Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino, Torino, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Ospedale San Bortolo, Vicenza, , Italy
Aso Co.,Ltd Iizuka Hospital, Iizuka, , Japan
St Marianna University Hospital, Kanagawa, , Japan
Nara Medical University Hospital, Kashihara-shi, , Japan
Kimitsu Chuo Hospital, Kisarazu-shi, , Japan
Nagasaki University Hospital, Nagasaki-shi, , Japan
JOHAS Osaka Rosai Hospital, Osaka, , Japan
Toranomon Hospital, Tokyo, , Japan
Toyama University Hospital, Toyama-shi, , Japan
Fujita Health University Hospital, Toyoake, , Japan
University of Tsukuba Hospital, Tsukuba-Shi, , Japan
Yokohama City University Medical Center, Yokohama, , Japan
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Chonnam National University Hospital, Gwangju, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan Si, , Korea, Republic of
NKI-AVL, Amsterdam, Amsterdam, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
Canisius-Wilhelmina Ziekenhuis, Nijmegen, , Netherlands
The Julius Center - Utrecht Science Park - Stratenum, Utrecht, , Netherlands
Hospital Garcia de Orta, Almada, , Portugal
Chbv - Hosp. Infante D. Pedro, Aveiro, , Portugal
Hosp. Sra. Da Oliveira - Guimaraes, Guimarães, , Portugal
Centro Hospitalar de Lisboa Central, Lisboa, , Portugal
Fund. Champalimaud, Lisbon, , Portugal
Hospital Beatriz Angelo, Loures, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia Espinho E P E, Vila Nova de Gaia, , Portugal
Centro Hospitalar de Trás os Montes e Alto-Douro, Vila Real, , Portugal
Hertzen Oncology Research Institute, Moscow, , Russian Federation
City Clinical Hospital #1, Nizhny Novgorod, , Russian Federation
Avicenna Medical Center, Novosibirsk, , Russian Federation
A. Tsyb Medical Radiological Research Center, Obninsk, , Russian Federation
BHI of Omsk region Clinical Oncology Dispensary, Omsk, , Russian Federation
Ultrasound Clinic 4D, Pyatigorsk, , Russian Federation
Saratov State Medical University, Saratov, , Russian Federation
Multifunctional clinical medical center 'Medical city', Tyumen, , Russian Federation
Bashkir State Medical University, Ufa, , Russian Federation
Hosp. Univ. A Coruna, A Coruña, , Spain
Hosp. Univ. Germans Trias I Pujol, Badalona, , Spain
Fund. Puigvert, Barcelona, , Spain
Hosp. Puerta Del Mar, Cadiz, , Spain
Hosp. Univ. Virgen de Las Nieves, Granada, , Spain
Hosp. de Jerez de La Frontera, Jerez De La Frontera, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. La Paz, Madrid, , Spain
Hosp. Univ. Hm Monteprincipe, Madrid, , Spain
Hosp. Virgen de La Victoria, Málaga, , Spain
Corporacio Sanitari Parc Tauli, Sabadell, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Chernihivskyi oblasnyi onkolohichnyi dyspanser, Chernihiv, , Ukraine
Asklepion LLC, Kiev, , Ukraine
Sumy Regional Clinical Oncology Centre, Sumy, , Ukraine
NHS Greater Glasgow and Clyde, Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust, Leeds, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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