ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
Condition(s) studied
Investigational drug(s) / intervention(s)
padeliporfin VTP: 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.
Study 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
Eligibility
Primary outcome measure(s)
- Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter — 28 +/- 3 days post last treatment
Primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces renal pelvis and ureter on endoscopic evaluation at the time of Primary Response Evaluation (PRE) (28 +/- 3 days post last treatment) during padeliporfin VTP induction treatment phase. This outcome will be determined dichotomously as either failure or success in achieving complete response. · Complete Response will be defined as absence of disease based on: * absence of visual tumor on endoscopy * no evidence of tumor on biopsy (if feasible) * negative urinary cytology by instrumented collection
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California - Irvine Medical Center | Irvine | California | |
| Keck School of Medicine at USC Medical Center | Los Angeles | California | |
| Emory University Hospital | Atlanta | Georgia | |
| The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center | Baltimore | Maryland | |
| Albany Medical College | Albany | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| The Ohio State University (OSU) | Columbus | Ohio | |
| The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center | Hershey | Pennsylvania | |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | |
| University of Texas Southwestern Medical Center | Dallas | Texas | |
| University of Washington | Seattle | Washington | |
| CHU de Lille - Hopital Claude Huriez | Lille | France | |
| HCL Hopital Edouard Herriot | Lyon | France | |
| Universitaetsklinikum Tuebingen | Tübingen | Germany | |
| Sheba Medical Center | Ramat Gan | Israel | |
| Hospital Universitario de A Coruña | A Coruña | Spain | |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04620239 on ClinicalTrials.gov ↗ ← All trials in Germany