Upper Tract
Urothelial
Cancer Clinical Trial (UTUC)

Upper Tract
Urothelial Cancer Clinical Trial

(UTUC)

Find out how you can help researchers learn about upper tract urothelial cancer (UTUC) and a possible UTUC therapy in the ENLIGHTED clinical trial (also known as clinical research study).

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.

Upper Tract Urothelial Cancer Clinical Trial Patient

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.



What is the purpose of the ENLIGHTED study?

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.


Upper Tract Urothelial Cancer Clinical Trial

See If You Are Eligible

If you meet these requirements, you may be eligible to participate.

Upper tract urothelial cancer age eligibility
Upper Tract Urothelial Cancer Eligibility

You're 18 years of age or older


New or low grade upper tract urothelial cancer
New or recurring low grade UTUC

You have a new or recurring low grade UTUC


Upper tract urothelial cancer biopsy
UTUC Biopsy

A biopsy and cytology confirmed disease (up to 2 biopsy locations with low grade tumors)


Study Center Locations

clinical trial map for upper tract urothelial cancer

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

glind@curcmb.com


Albany Medical College
Albany, NY 12208
518-262-8579

amcurologyresearch@amc.edu


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

spsutka@uw.edu


Johns Hopkins Hospital/The Sidney Kimmel Comprehensive Cancer Center Baltimore, MD
410-502-0017

Amaison1@jhmi.edu


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

sierra.williams@emory.edu


Hollings Cancer Center at Medical University of South Carolina (MUSC)

843-792-2306

tuckerr@musc.edu


University of California - Irvine Medical Center
714-456-6801

duffyp@hs.uci.edu


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

  • What is an investigational therapy?

    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).

  • What will happen during the study?

    Study participation could last up to 5 years and 4 months, and participants will be asked to do the following:

    • Attend visits and have assessments such as biopsies and cytologies to find out if you qualify for the study.
    • Receive study therapy 1 to 3 times for about 3 months (about 4 weeks apart each time).
    • Have follow-up visits** and receive additional study therapy for about 12 months (per study doctor recommendation).
    • Have long-term follow-up for up to 4 years (up to 5 phone interviews).
    • Follow all instructions from the study doctor/staff, including light protection instructions for 48 hours after receiving the study therapy.
    • Ask the study team any questions or let them know if you need more instruction. Take notes to remember what happened between visits and any questions for the study doctor or staff.
    • Notify the study team of any health changes or changes to contact information.

    **These visits may be skipped depending on the participant's body response to the study therapy.

  • Will I receive the study therapy if I join the study?

    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.

  • Have other people used padeliporfin VTP?

    Yes. ENLIGHTED is a Phase 3 study. The study therapy has been researched in a Phase 1 study in people with UTUC.

  • What are clinical research studies (trials)?

    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.

  • Why do people participate in clinical research studies?

    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.

  • What is informed consent?

    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.

  • Are clinical research studies safe?

    Clinical research studies follow a specific set of standards and are closely regulated to help keep all participants safe.

  • What if I have questions during the study?

    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.

  • Can I leave the study once it has started?

    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.

  • Can I see my regular doctor, or other doctors, during the study?

    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.

For Healthcare Professionals

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.

Primary study objective

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.

Study Therapy

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 Overview

Study participation could last about 5 years and 4 months, depending on how participants respond to the investigational study therapy.

Screening (0-4 weeks)

  • This phase will confirm participant eligibility with assessments including ureteroscopy, biopsy, and cytology.


Induction Treatment Phase (1-3 months)

  • Participants undergo anesthesia and receive the study therapy 1 to 3 times, about 4 weeks apart. If a participant does not achieve Complete Response (CR)* after 3 treatments (or if their disease has progressed as defined in the protocol), the participant will be discontinued from the Treatment Phases and enter the Long-term Follow-up Phase.


Maintenance Treatment Phase (12 months)

  • Participants who achieve CR* from Induction Treatment Phase will be followed for 12 months. Repeated maintenance with the study therapy will be provided for participants as determined by the study doctor.


Long-term Follow-up Phase (48 months)

  • Patients who achieve CR and then enter the maintenance treatment phase and who have a CR after the end of maintenance treatment phase will enter the Long-term Follow-up Phase and will be followed up for up to an additional 48 months in the Long-term Follow-up Phase or until recurrence, progression, death or loss to follow up, to document safety and ongoing response.

  • Patients discontinued from the treatment phases and who have received at least one padeliporfin VTP treatment will be followed up for additional 12 months in the long-term follow-up phase of the study from last VTP treatment.

*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.