Ferring | ABLE-32 | NCT06510374

About

Non-muscle invasive bladder cancer (NMIBC) is a cancer of the bladder lining that has not spread into the muscle wall. It is the most common type of bladder cancer, accounting for ~75% of diagnoses, with about 83,000 new US cases annually. Despite surgery and immunotherapy or chemotherapy instilled directly into the bladder, cancer returns in 50–70% of patients within five years. This high recurrence rate leads to repeated procedures and lifelong monitoring, significantly impacting quality of life. New treatments are urgently needed for intermediate-risk patients.

Purpose

This study aims to determine whether nadofaragene firadenovec (Adstiladrin®), a gene therapy instilled directly into the bladder, can extend recurrence-free survival compared to observation alone. Nadofaragene firadenovec delivers the interferon alpha-2b gene into bladder cells to stimulate an anti-tumor immune response. The primary objective is to measure how long patients remain free of cancer recurrence or progression. Secondary objectives include evaluating recurrence-free survival at 12 and 24 months and assessing the safety of the treatment.

Eligibility

• Adults with newly diagnosed or recurrent intermediate-risk NMIBC, per AUA/SUO guidelines
• Transurethral resection of bladder tumor (TURBT) completed within 60 days before enrolling
• No current or prior muscle-invasive or metastatic bladder disease
• No high-grade T1 (high-risk) NMIBC

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.