A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Trial Details

NCT ID
NCT06919965
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • TAR-210
  • Mitomycin C
  • Gemcitabine
Locations (sample)
  • Sun City, Arizona, United States|33.59754,-112.27182
  • Lakewood, Colorado, United States|39.70471,-105.08137
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Chicago Ridge, Illinois, United States|41.70142,-87.77922
  • Carmel, Indiana, United States|39.97837,-86.11804

Key Eligibility Criteria

  • Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumo…
  • Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) …
  • All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomizat…
  • Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction …

For full eligibility, visit ClinicalTrials.gov.

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