The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study

Official Title

A Phase 3 Multicentre Trial Evaluating the Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma

Summary:

The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial carcinoma tumours from the upper urinary tract. If this treatment will prove to be effective this will lead to the development of a new treatment approach for patients suffering from Low Grade Upper Urinary Urothelial Carcinoma (UTUC).

Trial Description

Primary Outcome:

• Complete Response (CR) Rate defined as percent of patients with CR at the Primary Disease Evaluation (PDE) Visit
• Adverse events rate

Secondary Outcome:

• Long Term Durability of Complete Response (CR)
• CR rate at 3, 6 and 9 month after the PDE.
• Partial response (PR) to treatment
• MMC level in the plasma for sub-group of patients (n=6)
• MMC level in the plasma for sub-group of patients (n=6)

Trial TC-UT-03 is a prospective, open label, single-arm trial, designed to assess the efficacy, safety, and tolerability of treatment with MitoGel™ instilled in the upper urinary system of patients with non-invasive low-grade (LG), UTUC. Upon signing of informed consent, the patients will undergo a screening visit for eligibility evaluation. Eligible patients will be treated with MitoGel™ once weekly for a total of 6 times; in a retrograde fashion. Patients who will demonstrate CR will be treated with MitoGel™ once monthly as a maintenance therapy for a total of 11 instillations or up to the first recurrence whichever comes first. Five (5) weeks (± 1 w) following the last instillation, the PDE Visit, during which safety and efficacy will be assessed, will take place. During this visit, the ablative effect of the MitoGel™ will be assessed visually, by upper tract washed urine cytology, and if there are remaining tumours, by biopsy or brush biopsy if technically feasible. Patient demonstrating CR at PDE will undergo monthly maintenance instillations of MitoGel™ up to 11 months post PDE. Safety follow-up for these patients will be done until one month post last instillation or at the end of the follow-up period in FU visit 12, which is the earlier. For patients who did not demonstrate Complete Response, to the extent that it is possible, all remaining tumours lesions will be biopsied. The patients shall undergo any additional surgical or other treatment the PI decides deem necessary to remove remaining tumour. An independent Data Monitoring Committee (DMC) was assigned to this trial. Accumulating safety, tolerability and efficacy data will be monitored periodically by the DMC according to a pre-specified process and frequency detailed in the DMC charter.

View this trial on ClinicalTrials.gov