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
Recruiting now · Phase 3
Conditions studied: Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
In brief
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.
Key facts
- Study ID
- NCT07480356
- Run by
- Protara Therapeutics
- People needed
- 284
- Starts
- 2026-05-29
- Expected to finish
- 2032-11-01
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 requirements prior to study entry
- 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 recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis
You may not qualify if…
- Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
- Central confirmed variant histology
- Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
- Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)
- Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history
- For more information on eligibility criteria, please contact the Sponsor.
Where it is running
- East Valley Urology Center of Arizona — Queen Creek, Arizona, United States (enrolling)
- Arkansas Urology — Little Rock, Arkansas, United States (enrolling)
- Michael Oefelein Clinical Trials — Bakersfield, California, United States (enrolling)
- Renown Regional Medical Center — St Louis, Missouri, United States (enrolling)
- START - Carolinas — Myrtle Beach, South Carolina, United States (enrolling)
- Arensia Kapitanivka - PPDS — Kapitanivka, Ukraine (enrolling)
Full record on ClinicalTrials.gov
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