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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
Sponsor: Janssen Research & Development, LLC
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2020-12-18
Completion Date
2027-09-30
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
TAR-200
TAR-200 will be administered transuretherally.
Cetrelimab
Cetrelimab will be administered.
Locations (144)
Del Sol Research Management, LLC
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
AZ Sint-Lucas Brugge
Assebroek, Belgium
AZ Sint-Jan Brugge
Bruges, Belgium
Hopital Erasme
Brussels, Belgium
Algemeen ziekenhuis Maria Middelares
Ghent, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Algemeen Ziekenhuis Delta
Roeselare, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
Exdeo Clinical Research Inc
Abbotsford British Columbia, 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
Hyères, France
Polyclinique de Limoges - Francois Chenieux
Limoges, France
Hôpital Edouard Herriot
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Centre de Cancerologie du Grand Montpellier
Montpellier, France
CHU Nimes
Nîmes, France
Hopital Saint Louis
Paris, France
Hôpital Universitaire Pitié-Salpêtrière
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, France
CHP Saint Gregoire
Saint-Grégoire, France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, France
Hopital Foch
Suresnes, France
Hopital Rangueil
Toulouse, France
Urologische Partnerschaft Koln UPK
Cologne, Germany
Urologicum Duisburg
Duisburg, Germany
Klinikum Herne - Urologie
Herne, Germany
Matthias Schulze - Germany
Markkleeberg, Germany
Urologie Neandertal Praxis Mettmann
Mettmann, Germany
Universitatsklinikum Munster
Münster, Germany
Schön Klinik Nürnberg Fürth
Nuremberg, Germany
Studienpraxis Urologie Nürtingen - Germany
Nürtingen, Germany
Urologische Praxis am Wasserturm - Germany
Würselen, Germany
Metropolitan General A E
Cholargós, Greece
Athens Medical Center
Marousi, 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 Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Satellite 1
Bari, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Ospedale San Martino 1
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, Japan
JOHAS Osaka Rosai Hospital
Osaka, Japan
Toranomon Hospital
Tokyo, Japan
Toyama University Hospital
Toyama, Japan
Fujita Health University Hospital
Toyoake, Japan
University of Tsukuba Hospital
Tsukuba, Japan
Yokohama City University Medical Center
Yokohama, Japan
Antoni van Leeuwenhoek
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
Uls Regiao Aveiro - Hosp. Infante D. Pedro
Aveiro, Portugal
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
Guimarães, Portugal
Centro Hospitalar de Lisboa Central
Lisbon, Portugal
Fund. Champalimaud
Lisbon, Portugal
Uls Loures Odivelas - Hosp. Loures
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, Russia
Privolzhsky District Medical Centre
Nizhny Novgorod, Russia
Avicenna Medical Center
Novosibirsk, Russia
A. Tsyb Medical Radiological Research Center
Obninsk, Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, Russia
Ultrasound Clinic 4D
Pyatigorsk, Russia
Saratov State Medical University
Saratov, Russia
Multifunctional clinical medical center 'Medical city'
Tyumen, Russia
Bashkir State Medical University
Ufa, Russia
Inje University Haeundae Paik Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
National Cancer Center
Goyang-si, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
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