Bladder cancer is the tenth most common type of cancer worldwide. The natural history of high-risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) is unpredictable; rates of recurrence vary from 15 percent (%) to 78%, and rates of progression to muscle invasion and metastasis vary from less than (<) 1 to 45%. The gemcitabine 225 milligrams (mg) intravesical delivery system (JNJ-17000139) product (hereafter, TAR-200) is an investigational integral product that is comprised of a drug and device components. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein 1 (PD-1). This study consists 3 periods: screening phase (up to 42 days); treatment phase (up to 2 years); follow up phase (up to 5 years). Total duration of study is up to 6 year and 7 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study.
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.