This study is a prospective, open-label, single-arm, multicenter Phase 2b trial designed to assess the efficacy and safety of UGN-102 treatment instilled in patients diagnosed with LG NMIBC, including newly diagnosed patients, and determined to have intermediate risk of progression, defined as 1 or 2 of the following: multiple tumors, tumors >3 cm, early recurrence (within 1 year of diagnosis), or frequent recurrence (>1 recurrence within 1 year of current diagnosis). Eligible patients will be treated with 6 weekly instillations of UGN-102.
UGN-102 is a reverse thermal hydrogel formulated with MMC. The product is specifically formulated to achieve a liquid state at 4°C and to transition to a water-soluble gel at body temperature. The advantage of delivering Mitomycin to the urinary bladder using UGN-102 relies on preclinical and clinical literature documenting that concentration and dwell time correlate directly with the therapeutic efficacy of MMC when used to treat Urothelial Carcinoma (UC)
The ablative effect of UGN-102 will be evaluated at the Primary Disease Evaluation (3 MONTH) assessment, which will take place 5 weeks ±1 week after the last weekly instillation (3 months after initiation of study medication). Response will be determined based on visual evaluation by cystoscopy (appearance, number, size, and location of the lesions) and, if there are remaining lesions, by histopathology of the remaining lesions. CR is defined as having no detectable disease (NDD) and will be assessed visually during cystoscopy and also upon urine cytology. In the event that the investigator is not sure, and there is suspect tissue, a small biopsy will be taken from the suspect tissue to confirm CR in addition to cystoscopy and urine cytology. Patients who achieve a CR will receive monthly maintenance treatments with UGN-102 and will be assessed at 6, 9, and 12 months after the first instillation of UGN-102 for evidence of disease recurrence. The group of patients considered nonresponders (non-CR) will discontinue the study and continue with standard of care according to their treating physician.
Safety will be determined based on physical examination, laboratory assessments, and a review of AEs. All safety data will be reviewed on an ongoing basis, including close review and follow up of any unexpected AE related to UGN-102 and qualified per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) as Grade 3 or 4.