RecruitingPHASE3INTERVENTIONAL

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study

This research, called the ENLIGHTED study, is testing a new way to treat early-stage bladder cancer that is found in the kidney or the tubes connecting it to the bladder (called upper tract urothelial carcinoma). The treatment, named padeliporfin VTP, uses light to target and destroy cancer cells. This study is for people with low-grade, non-invasive tumours (meaning they haven't spread deeply). Patients will receive the light-activated treatment and be closely watched to see if the cancer goes away completely and how long it stays away. The main goal is to find out how effective and safe this new treatment is for this specific type of cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Steba Biotech S.A.

Enrolment target

100

Start

22 Mar 2021

Estimated completion

25 Jan 2029

Transitional Cell Cancer of Renal Pelvis and Ureter

What is this study about?

This study, called ENLIGHTED, is investigating a new treatment for a type of early bladder cancer that starts in the kidney or the tubes (ureters) that carry urine from the kidneys to the bladder. This condition is known as upper tract urothelial carcinoma (UTUC). Specifically, the study is focusing on 'low-grade' and 'non-invasive' cancer, which means the cancer cells are slow-growing and have not spread into deeper layers of the tissue.

Currently, treatment for this type of cancer can involve surgery to remove part or all of the kidney or ureter. This study is looking into a less invasive option using a treatment called padeliporfin VTP. This involves using a special light-activated drug to target and destroy the cancer cells. The aim is to see if this treatment can successfully remove the cancer without needing major surgery, and how long the patient stays cancer-free afterwards.

Patients taking part will receive the padeliporfin VTP treatment, which involves up to three initial treatments. Doctors will then check carefully to see if all the cancer has gone. If it has, patients will be monitored over several months, and might receive further treatments if the cancer shows signs of returning. The study is important because it could offer a new way to treat this cancer more gently, helping to preserve kidney function and improve quality of life for patients.

Key takeaways

Targets early, non-invasive kidney/ureter cancer.
Uses a new light-activated drug called padeliporfin VTP.
Aims to remove cancer without major surgery.
Involves initial treatments and long-term monitoring.
Could help preserve kidney function.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have a small, non-invasive, low-grade tumour (cancer that hasn't spread deeply) in your kidney or ureter, which has been confirmed by a biopsy. The tumour should be between 5mm and 15mm across, and there can be up to two separate areas of cancer. You also need to be generally well enough to take part in the study activities.

You would not be able to join if you have cancer that has deeply spread or is high-grade (more aggressive) in your bladder or upper urinary tract. If you've had certain types of chemotherapy or medical treatments in the last two months, or if you are sensitive to light or have specific heart, lung, or liver problems, you wouldn't be able to participate. Also, if you're already in another medical study involving a new treatment, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have low-grade, non-invasive cancer in your kidney or ureter (diagnosed by biopsy)?
Is your tumour between 5mm and 15mm in size?
Are you generally well and fit enough for treatment?
Have you avoided certain chemotherapy or medical treatments in the last two months?
Do you have any conditions like severe heart, lung, or liver disease, or extreme light sensitivity?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first go through an 'Induction Treatment Phase'. This means you'll have up to three treatments with padeliporfin VTP, given about four weeks apart. Each treatment involves using a special light to activate the drug at the cancer site. After each treatment, doctors will check inside your kidney or ureter to see if the cancer has gone. If it hasn't completely gone after the first treatment, you can have up to two more.

Once all the cancer is gone after the initial treatments, you'll move into a 'Maintenance Treatment Phase'. During this time, you'll be regularly checked for 12 months to see if the cancer stays away. If the cancer starts to come back, and it's suitable, you might receive further padeliporfin VTP treatments. Overall, you will be followed up for several years, depending on your treatment response, but the active treatment phases are within the first year.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new treatment that might successfully remove your cancer without needing major surgery, helping you to keep your kidney and ureter. However, like all medical treatments, there are potential risks, which will be fully explained to you by the study team. These could include side effects from the treatment or complications from the procedures. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

University of California - Irvine Medical Center
Verified postcode
Irvine, United States· Recruiting
Keck School of Medicine at USC Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Emory University Hospital
Verified postcode
Atlanta, United States· Recruiting
The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center
Verified postcode
Baltimore, United States· Recruiting
Albany Medical College
Verified postcode
Albany, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
The Ohio State University (OSU)
Verified postcode
Columbus, United States· Recruiting
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Verified postcode
Hershey, United States· Recruiting
Medical University of South Carolina (MUSC)
Verified postcode
Charleston, United States· Recruiting
Carolina Urologic Research Center
Verified postcode
Myrtle Beach, United States· Recruiting
University of Texas Southwestern
Verified postcode
Dallas, United States· Recruiting
University of Washington
Verified postcode
Seattle, United States· Recruiting

Common questions

What is 'low-grade non-invasive' cancer?

It means the cancer cells are slow-growing and have not spread deeply into the tissue, making them easier to treat.

What is padeliporfin VTP?

It's a new treatment that uses a special drug activated by light to specifically target and destroy cancer cells while leaving healthy tissue alone.

How many treatments will I receive?

You could have up to three initial treatments to get rid of the cancer, and possibly more if the cancer returns later in the follow-up period.

How long will I be in the study?

You will have active treatment and monitoring for about a year, but you might be followed up for up to four years in total, depending on how your cancer responds.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point, and it won't affect your future medical care.

How to find out more

Eyal Morag, MD

eyal.morag@impactbiotech.com +97253 9656070 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.