The ENLIGHTED study is a clinical trial (research study) for people with upper tract urothelial cancer (UTUC) that is not invasive or aggressive and spreading slowly (low grade cancer). The study is testing the safety of the investigational study therapy and how effective it is at targeting low grade UTUC tumors.
Clinical Trial Information
The ENLIGHTED study is a clinical trial (research study) for people with upper tract urothelial cancer (UTUC) that is not invasive or aggressive and spreading slowly (low grade cancer). The study is testing the safety of the investigational study therapy and how effective it is at targeting low grade UTUC tumors.
The primary purpose of the study is to learn more about the effects and safety of the investigational study therapy targeting UTUC tumors. Investigational means that the study therapy has not been approved for use for UTUC, except in clinical research studies. What we learn from this study may help scientists and doctors develop the study therapy as a possible UTUC therapy.
See If You Are Eligible
If you meet these requirements, you may be eligible to participate.
You're 18 years of age or older
You have a new or recurring low grade UTUC
A biopsy and cytology confirmed disease (up to 2 biopsy locations with low grade tumors)
Study Center Locations
Find a study center near you.
Memorial Sloan Kettering Cancer Center, New York, NY 10021
646-422-4781
Carolina Urologic Research Center
Myrtle Beach, SC 29572
843-449-1010
Albany Medical College
Albany, NY 12208
518-262-8579
Penn State Health Milton S. Hershey Medical Center,
Hershey, PA
717-531-5930
urologyresearch@pennstatehealth.psu.edu
University of Washington
Seattle, WA
206-598-4294
Johns Hopkins Hospital/The Sidney Kimmel Comprehensive Cancer Center Baltimore, MD
410-502-0017
USC/Norris Comprehensive Cancer Center, Los Angeles, CA
323-865-0702
djaladat@usc.edu
Emory University Hospital
Atlanta, GA
404-778-7081
michael.paul.moulton@emory.edu
Hollings Cancer Center at Medical University of South Carolina (MUSC)
843-792-2306
University of California - Irvine Medical Center
714-456-6801
The Ohio State University (OSU) - The James Outpatient Care West Campus
614-293-6801
GUResearchCoordinators@osumc.edu
University of Texas Southwestern Medical Center
Vitaly.Margulis@UTSouthwestern.edu
Frequently Asked Questions
Investigational means that the study therapy has not been approved for use for UTUC except in clinical research studies.
Clinical research studies are undertaken to demonstrate the safety and effectiveness of a new therapy, are performed under control of regulatory authorities, and are necessary before approval of a new therapy by the regulatory authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Study participation could last up to 5 years and 4 months, and participants will be asked to do the following:
**These visits may be skipped depending on the participant's body response to the study therapy.
Yes. You will receive the study therapy up to 6 times, as determined by the study doctor. The study doctor will monitor how your body responds to each dose to decide if another one is needed.
Yes. ENLIGHTED is a Phase 3 study. The study therapy has been researched in a Phase 1 study in people with UTUC.
Clinical research studies, or trials, help scientists and doctors explore if new medical strategy, devices, or drugs are safe and effective in people for certain diseases.
Before any new drug or device can be prescribed as therapy for a specific condition, it must go through several rounds of clinical research. The study may take place at a hospital, clinic, university, or doctor’s office.
People participate in clinical research studies for different reasons. Some may participate because they want to learn more about their disease.
Others volunteer to participate because they want to help researchers learn more about a disease to potentially help them and others in the future.
Some may participate to have regular health monitoring and disease management adjustments that may otherwise take longer to notice.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains written information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Clinical research studies follow a specific set of standards and are closely regulated to help keep all participants safe.
You can ask questions of the study team at any time before, during, and after the study. Before agreeing to participate, make sure that you understand the responsibilities of study participants.
If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study doctor/staff at any time.
Study participation is completely voluntary. You do not need to take part in the study, and you can end your participation at any time, for any reason.
If you think you would like to stop participating in the study, talk to the study doctor/staff. If you decide you should leave the study early, the study doctor may ask that you return to the study center for a final visit to ensure your health and safety, but there will be no negative impact on future care you receive.
You can visit any doctor to meet your health needs during the study. You should let your study doctor know that you will be seeing another doctor and if any other medication has been prescribed. You should also let your other doctors know that you are participating in a clinical research study.
NOTE: Information on this webpage is applicable to Healthcare Professionals (HCPs) only.
The ENLIGHTED study is sponsored by Steba biotech. It is a Phase 3 clinical research study to explore the safety, effectiveness, and durability of padeliporfin vascular targeted photodynamic (VTP) therapy for targeting low grade upper tract urothelial cancer (UTUC) tumors. This is a global study being conducted the United States, France, Germany, Austria, Italy, Spain and Israel. Other countries may also participate.
To demonstrate the efficacy and durability of effect following padeliporfin vascular targeted photodynamic (VTP) therapy on low grade UTUC tumors in the calyces, renal pelvis, and ureter.
The investigational product, padeliporfin VTP, is a combination product of a photoactive drug (padeliporfin) administered intravenously and a device (VTP), which is part of a laser light delivery system. After drug administration, the light system delivers the light to the target lesion(s) in the upper tract urothelium.
Based on the data available to date, padeliporfin VTP appears to be well-tolerated at the dose range tested, and to effectively ablate targeted tumors in the majority of participants.
Study participation could last about 5 years and 4 months, depending on how participants respond to the investigational study therapy.
Screening (0-4 weeks)
Induction Treatment Phase (1-3 months)
Maintenance Treatment Phase (12 months)
Long-term Follow-up Phase (48 months)
*Note: Patient undergoing extirpative surgery of any part of the ipsilateral kidney or ureter for indications related to urothelial cancer will be considered as no longer having CR.
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