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ENLIGHTED Study for Upper Tract Urothelial Cancer

This study is testing a treatment called padeliporfin VTP for low-grade, non-invasive upper tract urothelial carcinoma (UTUC), a type of cancer in the kidney or ureter. You would receive padeliporfin intravenously (through a vein), and then light would be shined on the tumor area using a special fiber. The goal is to see if this treatment can make the tumors disappear. Doctors will check for tumor absence about 28 days after your last treatment. This study is for adults aged 18 and older who have new or returning UTUC that has been confirmed by a biopsy. The study is currently recruiting patients.

Study design
This is a Phase 3, open-label study, meaning both you and your doctors will know what treatment you are receiving. It plans to enroll 89 participants.
What's involved
You would receive 1 to 3 treatments with padeliporfin VTP, spaced about 4 weeks apart. You will have endoscopic exams to check the treatment's success, and follow-up for up to an additional 48 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed up for up to an additional 48 months after treatment, with the exact duration depending on your response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04620239

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Steba Biotech S.A.
~89 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:padeliporfin VTP

At a glance

Recruiting sites
0 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter
Measured over 28 +/- 3 days post last treatment

Conditions

Transitional Cell Cancer of Renal Pelvis and Ureter

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Where you'd take part

This study runs at 18 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Albany Medical College

    Albany, New Yorkno site contact published

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolinano site contact published

  • CHU de Lille - Hopital Claude Huriez

    Lille, Franceno site contact published

  • Emory University Hospital

    Atlanta, Georgiano site contact published

  • HCL Hopital Edouard Herriot

    Lyon, Franceno site contact published

  • Hospital Universitario de A Coruña

    A Coruña, Spainno site contact published

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spainno site contact published

  • Keck School of Medicine at USC Medical Center

    Los Angeles, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Vitaly Margulis, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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
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.

What this trial measures

  • Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter28 +/- 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