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

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 ID
NCT07480356
Phase
PHASE3
Sponsor
Protara Therapeutics
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • TARA-002
  • Investigator's Choice of Intravesical Chemotherapy
Locations (sample)
  • Queen Creek, Arizona, United States|33.24866,-111.6343
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Bakersfield, California, United States|35.37329,-119.01871
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Myrtle Beach, South Carolina, United States|33.68906,-78.88669

Key Eligibility Criteria

  • Male or female participants 18 years of age or older at the time of signing informed consent
  • Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requireme…
  • Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
  • Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most…

For full eligibility, visit ClinicalTrials.gov.

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