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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study (NCT04620239) is a Phase 3 interventional studying Transitional Cell Cancer of Renal Pelvis and Ureter, sponsored by Steba Biotech S.A.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Transitional Cell Cancer of Renal Pelvis and Ureter, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Transitional Cell Cancer of Renal Pelvis and Ureter subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Male and female patients 18 years or older - Able to understand and provide written willing to sign a consent form 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% - your organs (liver, kidneys, etc.) are working well enough based on blood tests defined at baseline as: - white blood cell count (ANC) at least 1,000/ μl, - platelet count at least 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * 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.

Treatments Being Tested

DRUG

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.

Locations (18)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04620239), the sponsor (Steba Biotech S.A.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04620239 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04620239?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04620239?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04620239. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04620239. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.