drugset / Trial / NCT04620239

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study

NCT04620239 ↗

NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2021-03-22
Primary completion
2026-03-30
Completion
2029-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Padeliporfin Other / unclassified 3.66 mg/kg Intravenous