Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer

Study acronym: ADVANCED-3
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Study sites: 10 to 11
    • Interventions: Investigator's Choice of Intravesical Chemotherapy (Drug), TARA-002 (Drug) to Investigator's Choice of Intravesical Chemotherapy (Drug), TARA-002 (Drug)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 15 of 15 entries
  2. Trial sites expanded: 6 → 10 locationsv3
  3. Recruitment opened
    • Trial sites expanded: 0 → 6 locations
    • Start date changed from estimate of May 2026 to May 29, 2026
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older. The main questions it aims to answer are: * Can the study drug help participants with this type of cancer? * Is the study drug safe? * What are the side effects of the study drug? Researchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.
Trial Details
NCT Number NCT07480356
Lead Sponsor Protara Therapeutics
Conditions
(from sponsor)		 Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
Related terms Carcinoma in Situ, Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
Enrollment 284 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov