RecruitingPhase 3NCT04620239

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

Multicenter 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

Sponsor

Steba Biotech S.A.

Enrollment

100 participants

Start Date

Mar 22, 2021

Study Type

INTERVENTIONAL

Conditions

Transitional Cell Cancer of Renal Pelvis and Ureter

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called ENLIGHTED) is testing a light-activated treatment delivered through a small scope directly into the urinary tract to treat low-grade upper urinary tract cancer (cancer in the kidney collecting system or ureter). This is a minimally invasive alternative to more extensive surgery. **You may be eligible if...** - You are 18 or older - You have new or returning low-grade, non-invasive cancer in the upper urinary tract (kidney or ureter) - Your cancer has been confirmed by biopsy - Your largest tumor is between 5 mm and 15 mm in size - You are healthy enough for the procedure **You may NOT be eligible if...** - Your cancer is high-grade or invasive - You have more than 2 sites of cancer involvement - Your overall health status is very poor - You have certain conditions that make the endoscopic procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpadeliporfin 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.

Locations(18)

University of California - Irvine Medical Center

Irvine, California, United States

Keck School of Medicine at USC Medical Center

Los Angeles, California, United States

Emory University Hospital

Atlanta, Georgia, United States

The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Albany Medical College

Albany, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Ohio State University (OSU)

Columbus, Ohio, United States

The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Washington

Seattle, Washington, United States

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

View Full Details on ClinicalTrials.gov

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NCT04620239