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A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations

The primary objective of this study is to compare DFS between participants receiving TAR-210 versus investigator s choice of intravesical chemotherapy. The key secondary objectives of this study are to compare TTNT, HG RFS, PFS, rate of diagnostic and therapeutic urological interventions, safety, and tolerability between TAR-210 and investigator s choice of intravesical chemotherapy.

Protocol Number: 082404
Phase: Phase III
Applicable Disease Sites: Urinary Bladder
Drugs Involved: TAR-210 (Erdafitinib)
Principal Investigator: Saum Ghodoussipour
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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