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

Running, not enrolling · Phase 3

Conditions studied: Transitional Cell Cancer of Renal Pelvis and Ureter

In brief

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

Key facts

Study ID

NCT04620239

Run by

Steba Biotech S.A.

People needed

89

Starts

2021-03-22

Expected to finish

2028-08-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients 18 years or older
• Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study
• New or recurrent low-grade, non-invasive UTUC disease
• Biopsy-proven disease . A concurrence of the central pathology reader will be required for eligibility.
• Up to 2 biopsy-proven sites of low-grade involvement with the largest tumor (index tumor) between 5 mm and 15 mm in diameter (as measured by endoscopy), both located in the calyces,renal pelvis or in the ureter of the ipsilateral kidney, with an absence of high-grade cells on cytology. (Ureter involvement should be in one anatomical location with no more than 20 mm of contiguous ureteral length)
• Karnofsky Performance Status ≥ 50%
• Adequate organ function defined at baseline as:
• ANC ≥1,000/ μl,
• Platelets ≥75,000/ μl, Hb ≥9 g/dl,
• INR ≤ 2
• Estimated glomerular giltration rate (eGFR) ≥30 ml/min (using CKD-EPI Method)
• Total serum bilirubin <3 mg/dL, AST/ALT ≤5× upper limit of normal

You may not qualify if…

• Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
• Carcinoma in situ (CIS) current or previous in the upper urinary tract
• History of invasive T2 or higher urothelial cancer in past 2 years
• Participation in another clinical study involving an investigational product within 1 month before study entry
• BCG or local chemotherapy treatment (including VEGF-targeted therapy) in the upper urinary tract within 2 months prior to inclusion
• Systemic chemotherapy treatment (including VEGF-targeted therapy) within 2 months prior to enrollment
• Prohibited medication that could not be adjusted or discontinued prior to study treatment
• Patients with photosensitive skin diseases or porphyria
• Any other medical or psychiatric co-morbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary or liver disease or current heavy smoker that, in the opinion of the study investigator, would make the patient a poor candidate for the study
• Pregnant or breast-feeding women.Women of childbearing potential (WOCBP) must undergo a negative serum pregnancy test prior to study entry.
• Men and women of reproductive potential not willing to observe conventional and effective birth control for the duration of treatment and for 90 days following the last padeliporfin VTP treatment.

Where it is running

• 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 Medical Center — 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

Full record on ClinicalTrials.gov

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