Protara | ADVANCED-3 | NCT07480356

About

Non-muscle invasive bladder cancer (NMIBC) is cancer confined to the bladder lining and makes up about three-quarters of new bladder cancer cases. High-grade disease, including carcinoma in situ (CIS), is more likely to return or spread into the bladder wall. Patients typically need repeated bladder instillations, cystoscopies, and biopsies, which can cause urinary symptoms and affect quality of life. BCG is the standard treatment, but supply shortages and treatment failures leave many patients with limited options.

Purpose

This Phase 3 study compares TARA-002, an investigational immune-stimulating treatment placed directly into the bladder, with the investigator’s choice of standard intravesical chemotherapy in about 284 adults who have not recently received BCG. Participants are randomly assigned to a group and know which treatment they receive. The primary goal is to observe the rate of complete response (no detectable cancer) at 6 months. The study will also assess how long responses last and patient safety. Participants treated with standard chemotherapy whose cancer returns may be able to cross over and receive TARA-002.

Eligibility

• Adults with high-grade non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without Ta/T1 papillary tumors
• Have never been treated with BCG, or have not received BCG within 24 months of the latest CIS diagnosis (or 2 or fewer BCG doses in that period)
• No history of cancer that spread to lymph nodes or distant sites, or of bladder cancer at stage T2 or higher
• No penicillin allergy

Benefits

If you qualify for the study, all study-related medical care and treatment will be provided to you at no cost. You may receive a stipend for your participation in the study.

Send us a message if you are interested in participating in a study.