A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)
1135 patients around the world
Available in Spain, United States, Argentina
Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of
bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC
patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an
intravesical drug delivery system regulated as an investigational drug. The drug
constituent consists of gemcitabine 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 mainstay of treatment for HR-NMIBC is
transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In
this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or
in combination with cetrelimab will be evaluated and compared against intravesical BCG.
The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total
duration of the study will be up to 5 years and 2 months. Efficacy, Safety,
pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the
study.
Janssen Research & Development, LLC
9Research sites
1135Patients around the world
This study is for people with
Bladder Cancer
Non-muscle-invasive bladder cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Sites
Centro Urológico Profesor Bengió - Córdoba
Recruiting
Urquiza 358, 1er Piso.
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Monseñor Pablo Cabrera 2941, Córdoba
Hospital Privado de la Comunidad
Recruiting
Córdoba 4545, Mar del Plata, Buenos Aires
Sanatorio Allende (Nueva Córdoba)
Recruiting
Hipolito Yrigoyen 384, Córdoba
Hospital Privado de Córdoba
Recruiting
Naciones Unidas 346, Córdoba
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH