TARA-002 vs chemotherapy for high-grade non-muscle invasive bladder cancer in adults not previously treated with BCG

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 trial compares intravesical TARA-002 to the investigator's choice of intravesical chemotherapy in adults with high-grade non-muscle invasive bladder cancer who are BCG-naive or have limited prior BCG exposure. Participants receive intravesical TARA-002 or another chemo option to see if the new therapy can better manage active disease. The study will monitor safety, side effects, and cancer response over the course of treatment. Enrollment is at multiple U.S. sites, with a lead sponsor of Protara Therapeutics. Eligibility requires age 18 or older, histologic confirmation of high-grade CIS (± Ta/T1) with active disease, and specific BCG exposure history.

Why it matters

Who can join: the full rules

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.

Where it's running

• East Valley Urology Center of Arizona
  Queen Creek, Arizona, United States Recruiting
• Arkansas Urology
  Little Rock, Arkansas, United States Recruiting
• Michael Oefelein Clinical Trials
  Bakersfield, California, United States Recruiting
• Urology of Greater Atlanta - Sandy Springs
  Atlanta, Georgia, United States Recruiting
• Renown Regional Medical Center
  St Louis, Missouri, United States Recruiting
• START - Carolinas
  Myrtle Beach, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Chief R&D Officer
• Email: clinicaltrials@protaratx.com
• Phone: 16468440337

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Liquid biopsy testing to identify, monitor, and predict recurrence in urothelial carcinoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.