A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Titre officiel

Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Sommaire:

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.

Description de l'essai

Primary Outcome:

• Overall Clinical Response (CR) Rate

Secondary Outcome:

• Durability of Response (DOR)
• Overall Survival (OS)
• Cohort 1 and 2: Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma
• Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies
• Number of Participants with Anti-cetrelimab Antibodies
• Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
• Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
• Number of Participants with Adverse Events (AEs) by Severity Grades
• Number of Product Quality Complaints (PQC)

Bladder cancer is the tenth most common malignancy worldwide. The natural history of high-risk Non-Muscle Invasive Bladder Cancer (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 TAR-200/gemcitabine (JNJ-17000139-AAC) product (hereafter, TAR-200) is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine minitablets, and osmotic minitablets containing urea as the osmotic agent. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds PD-1. This study consists 3 periods: screening phase (up to 30 days); treatment phase (up to 2 years); follow up phase (up to 5 years). Total duration of study is up to 5 years. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study.

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