Study on TAR-200 with Cetrelimab or Alone Compared to BCG for High-Risk Non-Muscle Invasive Bladder Cancer

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05714202

Provider View

This clinical trial is comparing the effectiveness of a new treatment using TAR-200, with or without the drug cetrelimab, against the standard BCG treatment in patients with high-risk non-muscle invasive bladder cancer who have not previously received BCG.

Patient Parameters

Program Overview

The study aims to find out if TAR-200, a new drug delivery system, either alone or combined with cetrelimab, is as effective as the standard BCG treatment for patients with high-risk non-muscle invasive bladder cancer (HR-NMIBC). The trial will look at how long patients remain free of cancer events with these treatments. Participants will be divided into three groups: one receiving TAR-200 with cetrelimab, another receiving TAR-200 alone, and the last group receiving BCG. The study will last up to 5 years and 2 months, including screening, treatment, and follow-up phases.

Description

Bladder cancer is a common type of cancer, and many cases are non-muscle invasive at the time of diagnosis. This study focuses on high-risk non-muscle invasive bladder cancer (HR-NMIBC), which requires careful treatment. TAR-200 is a new way to deliver the drug gemcitabine directly into the bladder. Cetrelimab is an antibody that helps the immune system fight cancer. The standard treatment for HR-NMIBC is surgery followed by BCG therapy. This study will test if TAR-200, with or without cetrelimab, can be a better alternative to BCG. Participants will go through a screening phase to ensure they meet the study criteria, followed by a treatment phase where they receive one of the study treatments, and a follow-up phase to monitor their health and cancer status. The study will assess the safety and effectiveness of the treatments, as well as how the body processes the drugs and any changes in cancer markers.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-grade non-muscle invasive bladder cancer (HR-NMIBC) and have not received BCG treatment before.
  • All visible cancer must be removed before starting the study.
  • Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
  • Any side effects from previous treatments must be mild or resolved before starting the study.
  • Must agree to participate in all study procedures.

Exclusion Criteria

  • Have or had muscle-invasive bladder cancer or cancer that has spread beyond the bladder.
  • Have had bladder cancer in other parts of the urinary system, unless treated with surgery more than 2 years ago.
  • Have any bladder or urethral conditions that could make the study treatments unsafe.
  • Have a history of producing large amounts of urine (more than 4000 mL in 24 hours).
  • Cannot have a permanent catheter, but occasional catheter use is allowed.

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