Study on TAR-200 with Cetrelimab and Cetrelimab Alone for Muscle-Invasive Bladder Cancer

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04919512

Provider View

This clinical trial is testing the effects of a new treatment, TAR-200, used with or without the drug cetrelimab, in patients with muscle-invasive bladder cancer. The study aims to see how well these treatments work against tumors.

Patient Parameters

Program Overview

The study is designed to evaluate how well the combination of TAR-200 and cetrelimab, as well as cetrelimab alone, can fight bladder cancer that has invaded the muscle. TAR-200 is a special system that delivers medication directly into the bladder, while cetrelimab is a type of immunotherapy that helps the immune system attack cancer cells. The study will last up to 2 years and 6 months and will include different phases: screening, treatment, and follow-up. Researchers will check the effectiveness, safety, and other important factors of the treatments at various times during the study.

Description

Bladder cancer is a common type of cancer worldwide, and about 25% of new cases are muscle-invasive at diagnosis. This means the cancer has spread into the muscle layer of the bladder. Unfortunately, about half of these cases may eventually spread to other parts of the body. The standard treatment for muscle-invasive bladder cancer often involves surgery to remove the bladder. This study is exploring a new treatment option using TAR-200, which delivers the drug gemcitabine directly into the bladder, and cetrelimab, an immunotherapy drug. The study will include a screening phase to determine eligibility, a treatment phase where participants receive the study drugs, and a follow-up phase to monitor outcomes. The study will assess how well the treatments work, their safety, and other important factors over a period of up to 2 years and 6 months.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with muscle-invasive bladder cancer within 120 days before joining the study.
  • Tumors must be mostly urothelial in type, but not small cell or neuroendocrine.
  • No remaining tumor or a tumor size of 3 cm or less after initial surgery.
  • Eligible and willing to undergo bladder removal surgery.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Normal thyroid function or stable on medication.
  • Any side effects from previous surgeries must be mild or resolved before starting the study.

Exclusion Criteria

  • No prior chemotherapy, targeted therapy, or radiation within 2 weeks before starting the study.
  • No advanced cancer spread (cT4b, N1-3, or M1) based on recent scans.
  • No bladder or urethral issues that could interfere with the TAR-200 device.
  • No previous chemotherapy for bladder cancer.
  • Not currently in another clinical trial or recently completed one within 4 weeks.
  • No bladder perforation during recent diagnostic procedures, unless healed before starting the study.

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