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

Brief description of study

The purpose of the study is to determine the efficacy and safety of TAR-200 in combination with Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in participants with BCG-unresponsive high risk Muscle Invasive Bladder Cancer (NMIBC). 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.


Clinical Study Identifier: s20-01697
ClinicalTrials.gov Identifier: NCT04640623
Principal Investigator: Katie S. Murray.
Other Investigators: Victor Ricardo Adorno Febles, James S Wysock, Samir Taneja, Scot Niglio, William C Huang, Hank Ng, David R. Wise.


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