At a glance
ClinicalIndex Comparison Record- ✓Low-grade, non-invasive UTUC disease
- ✓Biopsy-proven disease with central pathology reader confirmation
- ✓Up to 2 biopsy-proven sites with index tumor 5-15 mm diameter
- ✓Tumors located in calyces, renal pelvis, or ipsilateral ureter
- ✕Current high-grade or muscle invasive bladder urothelial carcinoma
- ✕Current or previous carcinoma in situ (CIS) in upper urinary tract
- ✕History of invasive T2 or higher urothelial cancer in past 2 years
- ✕BCG or local chemotherapy in upper urinary tract within 2 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04620239Phase 3RecruitingMonitorUpdated 4mo ago · Completion was 3mo agoMulticenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (Padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer
In Brief
A Phase 3 clinical trial evaluating padeliporfin VTP for Transitional Cell Cancer of Renal Pelvis and Ureter. Currently recruiting, targeting 100 participants across 18 sites in 5 countries.
Signals
Detailed Summary
This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment
Study Details
Timeline
Interventions
During treatment, placement at the target area of an optical light fiber, through the working channel of the ureteroscope. Intravenous administration of padeliporfin at the dose of 3.66 mg/kg infused over 10 minutes. Each target area will be illuminated for 10 minutes.