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NCT04620239 · ClinicalTrials.gov registry record · Phase 3
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
A Phase 3 study of Transitional Cell Cancer of Renal Pelvis and Ureter, sponsored by Steba Biotech S.A..
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 18
- Study locations
NCT04620239: Recruiting Phase 3 study of Transitional Cell Cancer of Renal Pelvis and Ureter, sponsored by Steba Biotech S.A..
NCT04620239 is a Phase 3 study of Transitional Cell Cancer of Renal Pelvis and Ureter that is actively recruiting participants, run by Steba Biotech S.A.. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04620239, a Phase 3 study of Transitional Cell Cancer of Renal Pelvis and Ureter, is actively recruiting participants, sponsored by Steba Biotech S.A..
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 18
- Study locations
Study 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
Primary Outcome
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 evide
Conditions Studied
Interventions
- DRUG padeliporfin VTP
Study Locations (18)
Other
- CHU de Lille - Hopital Claude Huriez - Lille
- HCL Hopital Edouard Herriot - Lyon
- Universitaetsklinikum Tuebingen - Tübingen
- Sheba Medical Center - Ramat Gan
- Hospital Universitario de A Coruña - A Coruña
- Hospital Universitario Vall d'Hebron - Barcelona
California
- University of California - Irvine Medical Center - Irvine
- Keck School of Medicine at USC Medical Center - Los Angeles
New York
- Albany Medical College - Albany
- Memorial Sloan Kettering Cancer Center - New York
South Carolina
- Medical University of South Carolina (MUSC) - Charleston
- Carolina Urologic Research Center - Myrtle Beach
Georgia
- Emory University Hospital - Atlanta
Maryland
- The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center - Baltimore
Ohio
- The Ohio State University (OSU) - Columbus
Pennsylvania
- The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2029-01-25 |
| Phase | Phase 3 |
What NCT04620239 shows while recruiting
NCT04620239 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Transitional Cell Cancer of Renal Pelvis and Ureter appearing as the primary indexed condition, and to 1 intervention - of which padeliporfin VTP is the first listed.
NCT04620239 lists 18 locations in 10 states (Other, California, New York).
Frequently Asked Questions
What is clinical trial NCT04620239 about?
NCT04620239 is a clinical study titled "ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study". 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 padeli...
What is the current status of trial NCT04620239?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2021-03-22. Estimated completion is 2029-01-25.
What conditions does trial NCT04620239 study?
This clinical trial studies the following conditions: Transitional Cell Cancer of Renal Pelvis and Ureter.
What interventions are being tested in trial NCT04620239?
The interventions under investigation include: padeliporfin VTP (DRUG).
Who is sponsoring clinical trial NCT04620239?
This trial is sponsored by Steba Biotech S.A., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04620239 being conducted?
This trial has 18 study locations across California, Georgia, Maryland, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04620239's enrollment target sits among peer trials
100 1682nd of 2000 higher than 288 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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