Toxicity to various agents Trials in Disease

Study on Methoxsalen for Treating Immune-Related Side Effects in Patients After Immunotherapy

This trial is designed to help patients who have developed immune-related side effects after receiving cancer immunotherapy treatments. These side effects occur when the immune system, activated by cancer treatment, mistakenly attacks healthy parts of the body.

Who can participate:

This study is open to adults aged 18 and older who can read and speak German. Participants must have received specific types of cancer immunotherapy in the past 24 months, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies. Most importantly, they must be experiencing immune-related side effects that have not improved after at least 72 hours of steroid treatment.

The trial accepts patients with several types of immune-related problems:

• Colitis: Severe diarrhea with at least 4 more bowel movements than usual per day
• Hepatitis: Elevated liver enzymes at least three times higher than normal levels
• Pneumonitis: Lung inflammation affecting more than 25% of the lung, with symptoms like cough, breathing difficulties, or chest pain
• Dermatitis: Skin rash covering 30% or more of the body with moderate to severe symptoms

Patients must be able to perform daily activities reasonably well and agree to attend scheduled visits and undergo required blood tests. Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding. Sexually active participants must use appropriate contraception during the study and for 5 months afterward.

Who cannot participate:

The study excludes patients who have not experienced immune-related side effects from immunotherapy, those outside the specified age range, and individuals who belong to vulnerable populations requiring special protection, such as children or pregnant women.

What the trial is studying:

The main goal of this research is to evaluate whether extracorporeal photopheresis (ECP) is safe and effective for treating immune-related side effects that haven't responded to steroids. The study aims to determine if fewer than 50% of patients experience serious adverse events during treatment. Researchers will also measure how quickly patients respond to treatment at 6 and 12 weeks, how long the benefits last, and whether patients can reduce or stop other immunosuppressive medications.

Treatment being tested:

The investigational treatment is extracorporeal photopheresis (ECP), which uses methoxsalen (brand name UVADEX). This procedure involves removing a small amount of blood from the patient, treating it with methoxsalen and exposing it to ultraviolet light outside the body, then returning it to the patient. This process is thought to help modify the immune response by promoting regulatory immune cells and changing the balance of immune signaling molecules. The treatment is designed specifically for patients whose symptoms have not improved with steroids and possibly one additional therapy.

Participants will be closely monitored throughout the study for any side effects and to track their progress. The trial is expected to conclude by the end of 2026.