Study Comparing TAR-200 and Chemotherapy for Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer After BCG Treatment

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06211764

Provider View

This clinical trial is comparing two treatments, TAR-200 and intravesical chemotherapy, to see which is more effective in preventing the return of high-risk non-muscle-invasive bladder cancer in patients who have had a recurrence after BCG therapy and cannot or choose not to have bladder removal surgery.

Patient Parameters

Program Overview

The aim of this study is to determine which treatment, TAR-200 or intravesical chemotherapy, is better at keeping bladder cancer from coming back in patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) that has returned within a year after their last BCG treatment. This study is for patients who have decided against or are not able to have their bladder surgically removed.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with papillary tumors only, classified as high-grade Ta or any T1, without carcinoma in situ (CIS).
  • Tumors must mainly be of urothelial (transitional cell) type, but not neuroendocrine or small cell types.
  • Must be unable or have chosen not to undergo bladder removal surgery (Radical Cystectomy).
  • Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have carcinoma in situ (CIS) at any time from diagnosis of recurrent HR-NMIBC to the start of the study.
  • Have or have had muscle-invasive, locally advanced, non-removable, or metastatic bladder cancer.
  • Have any bladder or urethral conditions that could make it unsafe to use or remove TAR-200, as judged by the study doctor. Men with tumors in the prostatic urethra are excluded.
  • Have a history of excessive urination, with more than 4000 milliliters of urine in 24 hours.
  • Cannot have a permanent catheter, but occasional catheter use is allowed.
  • Have previously been treated with TAR-200.

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