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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

Comparing TARA-002 and standard chemotherapy for bladder cancer patients.

Recruiting
18 years and older
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study tests if a new drug, TARA-002, can help treat high-grade non-muscle invasive bladder cancer (NMIBC) in adults who haven't tried BCG, a common treatment. NMIBC is a type of bladder cancer that hasn't spread to muscle tissue. The goal is to see if TARA-002 is effective and safe, and to learn about any side effects it might have compared to traditional chemotherapy.

To join, participants must be adults aged 18 or older and agree to the study conditions. They should have a specific type of bladder cancer confirmed by a lab test and should not have a history of certain other types of cancer or penicillin allergy. Those who have tried BCG within the last two years are mostly excluded.

  • This study involves comparing TARA-002 to chemotherapy.
  • Participants must avoid BCG treatment during the study.
  • Eligibility requires specific medical conditions and consent.
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Study details
    Bladder (Urothelial
    Transitional Cell) Cancer
    Non-Muscle Invasive Bladder Carcinoma
    Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

NCT07480356

Protara Therapeutics

17 October 2026

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