Actively Recruiting
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
Led by Steba Biotech S.A. · Updated on 2026-02-04
100
Participants Needed
18
Research Sites
409 weeks
Total Duration
On this page
Sponsors
S
Steba Biotech S.A.
Lead Sponsor
P
PrimeVigilance
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Able to understand and provide written informed consent and willing to comply with study procedures
- New or recurrent low-grade, non-invasive upper tract urothelial carcinoma
- Biopsy-proven disease confirmed by central pathology review
- Up to 2 biopsy-proven tumor sites with largest tumor between 5 mm and 15 mm, located in calyces, renal pelvis, or ureter of the same kidney
- No high-grade cells on urinary cytology
- Karnofsky Performance Status of 50% or higher
- Adequate organ function including ANC 2,000/bcL, platelets 75,000/bcL, hemoglobin 9 g/dL, INR 2, eGFR 30 ml/min, total serum bilirubin <3 mg/dL, and AST/ALT 5 times upper limit normal
You will not qualify if you...
- Current high-grade or muscle invasive urothelial carcinoma of the bladder
- Carcinoma in situ in upper urinary tract, current or past
- History of invasive T2 or higher urothelial cancer in past 2 years
- Participation in another investigational study within 1 month before entry
- BCG or local chemotherapy in upper urinary tract within 2 months prior to inclusion
- Systemic chemotherapy within 2 months prior to enrollment
- Use of prohibited medications that cannot be adjusted before treatment
- Photosensitive skin diseases or porphyria
- Serious medical or psychiatric conditions making participation unsafe
- Pregnant or breastfeeding women
- Men and women of reproductive potential unwilling to use effective birth control during treatment and for 90 days after last treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
University of California - Irvine Medical Center
Irvine, California, United States, 92868
Actively Recruiting
2
Keck School of Medicine at USC Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
Albany Medical College
Albany, New York, United States, 12208
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
The Ohio State University (OSU)
Columbus, Ohio, United States, 43210
Actively Recruiting
8
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
9
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
10
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
11
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
12
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
13
CHU de Lille - Hopital Claude Huriez
Lille, France, 59037
Actively Recruiting
14
HCL Hopital Edouard Herriot
Lyon, France, 69437
Actively Recruiting
15
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
16
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
17
Hospital Universitario de A Coruña
A Coruña, Spain, 15006
Actively Recruiting
18
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
E
Eyal Morag, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here