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ACTIVE NOT RECRUITING
NCT04919512
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

TAR-200

TAR-200 will be administered.

BIOLOGICAL

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