ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
Part of paid clinical trials in Irvine, California.
- Sponsor
- Steba Biotech S.A.
- Study ID
- NCT04620239
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Transitional Cell Cancer of Renal Pelvis and Ureter
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- padeliporfin VTP — DRUGDuring 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.
Study Details
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
Key Dates
- Start date
- Mar 22, 2021
- Status verified
- Feb 2026
- Primary completion
- Mar 30, 2026
- Completion
- Jan 25, 2029
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: padeliporfin VTPInduction Treatment phase:1-3 padeliporfin VTP treatments provided 4 weeks (28 +/-3 days) apart. Maintenance Treatment Phase: Repeated maintenance VTP treatments during this period will be provided for patients who show evidence of tumor recurrence that is deemed treatable.
Primary Outcome Measure
Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter [ Time Frame: 28 +/- 3 days post last treatment ]
Central Contacts
- Eyal Morag, MD+97253 9656070
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California - Irvine Medical Center | Irvine | California | 92868 | Edward Uchio, MD |
| Keck School of Medicine at USC Medical Center | Los Angeles | California | 90033 | Hooman Djaladat, MD |
| Emory University Hospital | Atlanta | Georgia | 30322 | Kenneth Ogan, MD |
| The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | Nirmish Singla, MD |
| Albany Medical College | Albany | New York | 12208 | Prof. Ronald Kaufman, MD |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Jonathan Coleman, MD Eugene Pietzak,, MD |
| The Ohio State University (OSU) | Columbus | Ohio | 43210 | Ahmad Shabsigh, MD |
| The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | Jay Raman, MD |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | Robert Grubb, MD |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | Neal Shore, MD |
| University of Texas Southwestern | Dallas | Texas | 75390 | Vitaly Margulis, MD |
| University of Washington | Seattle | Washington | 98195 | Sarah Psutka, MD |