Spots Global Cancer Trial Database for A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
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Trial Identification
Brief Title: A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
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
Study ID: NCT04919512
Conditions
Study Description
Brief 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.
Detailed Description: Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent (%) of all new bladder cancer participants present with muscle invasive bladder cancer (MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant metastases. The TAR-200/ gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine minitablets and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The standard of care in MIBC includes radical cystectomy (RC) with urinary diversion and is considered the preferred treatment option for participants who are considered surgical candidates. Study consists of a Screening phase, Treatment phase and follow-up phase. The total duration of study will be up to 2 years and 6 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during this study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Rochester, Minnesota, United States
Ellis Fischel Cancer Center, Columbia, Missouri, United States
Washington University School Of Medicine - Center For Advanced Medicine (CAM), Saint Louis, Missouri, United States
David C. Pratt Cancer Center, Saint 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
Montefiore Medical Center, Bronx, New York, United States
New York University Langone Medical Center, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Associated Medical Professionals, Syracuse, 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, Brugge, , Belgium
Algemeen Ziekenhuis Sint-Jan, Brugge, , 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, Creteil, , 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 Nîmes, Nimes, , France
Hopital Bichat Claude Bernard, Paris Cedex 18, , France
Hopital Europeen Georges-Pompidou, 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
Vivantes Klinikum Am Urban, Berlin-Kreuzberg, , Germany
Staedtisches Klinikum Braunschweig, Braunschweig, , Germany
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus, Frankfurt am Main, , Germany
Universitaetsklinikum Halle Saale, Halle Saale, , Germany
Marien hospital Herne, Herne, , Germany
Universitatsklinikum Munster, Muenster, , 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 Yafo, , Israel
Ospedale San Giuseppe Moscati di Avellino, Avellino, , Italy
Ospedale Civile Ramazzini, Carpi, , Italy
SPDC Villa Scassi, Genova, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, , 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
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
Samsung Medical Center, Gangnam Gu, , Korea, Republic of
National Cancer Center, Goyang-Si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , 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
Ziekenhuisgroep Twente, Almelo, , Netherlands
Haga ziekenhuis, Den Haag, , Netherlands
Radboud Umcn, Nijmegen, , Netherlands
Canisius-Wilhelmina Ziekenhuis, Nijmegen, , Netherlands
Hosp. Univ. A Coruna, A Coruna, , 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
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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