ENLIGHTED Study: Light-Activated Treatment for Upper Tract Urothelial Cancer

Sponsor: Steba Biotech S.A.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04620239

Provider View

This study is testing a new treatment called padeliporfin for patients with low-grade, non-invasive upper tract urothelial cancer in the kidney or ureter. The treatment involves two phases and long-term follow-up to monitor its effectiveness and safety.

Patient Parameters

Program Overview

The ENLIGHTED study is a phase 3 clinical trial exploring the use of padeliporfin, a light-activated treatment, for patients with low-grade, non-invasive upper tract urothelial carcinoma (UTUC) in the kidney or ureter. The study includes an Induction Treatment Phase and a Maintenance Treatment Phase, followed by a long-term follow-up period of up to 48 months to assess the treatment's effectiveness and safety.

Description

Induction Treatment Phase:

  • Patients will receive 1 to 3 treatments with padeliporfin, spaced about 4 weeks apart.
  • The goal is to achieve a Complete Response (CR), meaning no visible tumor, negative urine tests, and no tumor on biopsy.
  • If CR is not achieved after 3 treatments, the treatment will be considered unsuccessful, and the patient will not continue in the treatment phases.

Maintenance Treatment Phase:

  • Patients who achieve CR will enter this phase, lasting 12 months.
  • During this time, patients will be monitored for tumor recurrence and may receive additional treatments if low-grade tumors reappear.
  • Tumors must be small (5-15 mm) and limited to specific areas to qualify for further treatment.

Long Term Follow-up Phase:

  • After completing the maintenance phase, patients may be followed for up to 48 more months.
  • This phase involves monitoring for disease outcomes and any side effects from the treatment.
  • No additional padeliporfin treatments will be given during this time.
  • Patients will have assessments at 18 and 24 months, and annually for up to 5 years, to track safety and response.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 or older.
  • Able to understand and sign a consent form and willing to follow study procedures.
  • Have new or returning low-grade, non-invasive UTUC.
  • Disease confirmed by biopsy, with central pathology review.
  • Up to 2 sites of low-grade tumors, each 5-15 mm in size, located in the kidney or ureter.
  • No high-grade cells in urine tests.
  • Karnofsky Performance Status of 50% or higher.
  • Adequate organ function, including:
    • Neutrophil count ≥1,000/μl
    • Platelets ≥75,000/μl
    • Hemoglobin ≥9 g/dl
    • INR ≤ 2
    • eGFR ≥30 ml/min
    • Total bilirubin <3 mg/dL, AST/ALT ≤5× normal limit

Exclusion Criteria

  • Current high-grade or muscle-invasive bladder cancer.
  • Current or past carcinoma in situ in the upper urinary tract.
  • History of invasive T2 or higher urothelial cancer in the past 2 years.
  • Participation in another clinical study within 1 month before this study.
  • Recent BCG or local chemotherapy in the upper urinary tract.
  • Recent systemic chemotherapy.
  • Use of prohibited medications that cannot be adjusted.
  • Photosensitive skin diseases or porphyria.
  • Medical or psychiatric conditions that make participation unsafe.
  • Pregnant or breastfeeding women.
  • Men and women not willing to use effective birth control during and after treatment.

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