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A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.
Official title: A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
163
Start Date
2022-07-07
Completion Date
2026-03-31
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
TAR-200
TAR-200 will be administered.
Cetrelimab
Cetrelimab will be administered.
Locations (109)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States
UAMS Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States
Arkansas Urology
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Genesis Research
San Diego, California, United States
Colorodo Urology- St. Anthony Hospital
Golden, Colorado, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, United States
DuPage Medical Group
Lisle, Illinois, United States
Urology of Indiana
Indianapolis, Indiana, United States
First Urology
Jeffersonville, Indiana, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States
University Of Maryland Medical Center
Baltimore, Maryland, United States
Penn Medicine - PerelmanCenter for Advanced Medicine
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Michigan Institute of Urology, PC
Troy, Michigan, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic 1
Rochester, Minnesota, United States
Ellis Fischel Cancer Center
Columbia, Missouri, United States
Washington University School Of Medicine - Center For Advanced Medicine (CAM)
St Louis, Missouri, United States
David C. Pratt Cancer Center
St Louis, Missouri, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Mount Sinai Queens Infusion Center
Astoria, New York, United States
New York University Langone Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Associated Medical Professionals
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates
Nashville, Tennessee, United States
Houston Metro Urology
Houston, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Washington School of Medicine
Seattle, Washington, United States
AZ Sint Jan Brugge Oostende AV
Bruges, Belgium
Algemeen Ziekenhuis Sint-Jan
Bruges, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Hopital de Jolimont
Haine Saint Paul La Louviere, Belgium
ZNA Jan Palfijn
Merksem, Belgium
Centre Interuniversitaire Ambroise Pare - Ambroise Paré
Mons, Belgium
Clinique Tivoli Ducos
Bordeaux, France
ICH Hopital A. Morvan
Brest, France
Hopital Henri Mondor
Créteil, France
Hôpital Privé Le Bois
Lille, France
Polyclinique de Limoges - Francois Chenieux
Limoges, France
Hopital de la Timone
Marseille, France
CHU Montpellier
Montpellier, France
CHU Nimes
Nîmes, France
Hopital Europeen Georges-Pompidou
Paris, France
Hopital Bichat Claude Bernard
Paris, France
Hospices Civils de Lyon HCL
Pierre-Bénite, France
Clinical La Croix Du Sud - Ramsay Santé
Quint-Fonsegrives, France
HIA se Sainte-Anne - Toulon
Toulon, France
Clinique Pasteur
Toulouse, France
Staedtisches Klinikum Braunschweig
Braunschweig, Germany
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
Frankfurt am Main, Germany
Universitaetsklinikum Halle Saale
Halle, Germany
Marien hospital Herne
Herne, Germany
Vivantes Klinikum Am Urban
Kreuzberg, Germany
Universitatsklinikum Munster
Münster, Germany
Rambam Health Care Campus
Haifa, Israel
Carmel Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center - Hasharon Hospital
Petah Tikva, Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Ospedale San Giuseppe Moscati di Avellino
Avellino, Italy
Ospedale Civile Ramazzini
Carpi, Italy
SPDC Villa Scassi
Genova, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Istituto Dei Tumori Di Milano
Milan, Italy
Istituto Europeo di Oncologia
Milan, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
ASL Napoli 2 Nord-SM delle Grazie Hospital
Pozzuoli, Italy
Istituto Nazionale Tumori Regina Elena
Roma, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, Italy
Ziekenhuisgroep Twente
Almelo, Netherlands
Radboud Umcn
Nijmegen, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Haga ziekenhuis
The Hague, Netherlands
Inje University Haeundae Paik Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Samsung Medical Center
Gangnam Gu, South Korea
National Cancer Center
Goyang-si, South Korea
Korea University Anam Hospital
Seoul, 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
Fund. Puigvert
Barcelona, Spain
Hosp. Univ. San Cecilio
Granada, Spain
Clinica Univ. de Navarra
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hosp Virgen de La Victoria
Málaga, Spain
Hosp. Univ. Marques de Valdecilla
Santander, Spain
Barts Health NHS Trust
London, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
Preston, United Kingdom