NCT07480356 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
| NCT ID | NCT07480356 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Protara Therapeutics |
| Condition | Bladder (Urothelial, Transitional Cell) Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 284 participants |
| Start Date | 2026-05-29 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 284 participants in total. It began in 2026-05-29 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 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 Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07480356 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder (Urothelial, Transitional Cell) Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07480356 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 284 participants.
Is NCT07480356 currently recruiting?
Yes, NCT07480356 is actively recruiting participants. Contact the research team at clinicaltrials@protaratx.com for enrollment information.
Where is the NCT07480356 trial being conducted?
This trial is being conducted at Queen Creek, United States, Little Rock, United States, Bakersfield, United States, St Louis, United States and 2 additional locations.
Who is sponsoring the NCT07480356 clinical trial?
NCT07480356 is sponsored by Protara Therapeutics. The trial plans to enroll 284 participants.
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