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

1 1 1 1

What is this study about?

This clinical trial is focused on studying the treatment of immune-related adverse events that occur after receiving immunotherapy. These adverse events can include conditions such as colitis, pneumonitis, hepatitis, and dermatitis, which are side effects that some patients experience after their immune system is activated by cancer treatments known as immune checkpoint inhibitors. The treatment being tested in this study is called extracorporeal photopheresis (ECP), which involves a process where blood is treated outside the body to help manage these side effects. The medication used in this process is called methoxsalen, marketed under the name UVADEX.

The purpose of the study is to determine the safety and effectiveness of ECP in treating these immune-related side effects. Participants in the study will receive ECP treatment and will be monitored over a period of time to see how well the treatment works and to check for any side effects. The study will also look at how quickly patients respond to the treatment and how long the benefits last. The study aims to provide valuable information on whether ECP can be a safe and effective option for managing these challenging side effects of immunotherapy.

Throughout the study, participants will undergo regular assessments to track their progress and any changes in their condition. The study will help researchers understand the potential of ECP as a treatment option for patients who experience these immune-related side effects, offering hope for better management of these conditions in the future.

1 joining the study

Upon joining the study, the patient must provide written informed consent. This involves signing a document that confirms understanding of the study’s requirements and agreeing to participate.

The patient must be at least 18 years old and have adequate German language skills. A negative pregnancy test is required for women of childbearing potential.

2 eligibility confirmation

The patient must have experienced immune-related adverse events after receiving specific cancer treatments, such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.

These adverse events may include conditions like colitis, hepatitis, pneumonitis, or dermatitis, which have not improved after initial steroid treatment.

3 treatment initiation

The treatment involves extracorporeal photopheresis (ECP), a procedure where blood is treated outside the body. The medication used is methoxsalen, administered as a solution for blood fraction modification.

The treatment is designed to address adverse events that have not responded to steroids and possibly one additional therapy.

4 treatment schedule

The patient will undergo ECP therapy, with the objective of evaluating the safety and effectiveness of this treatment for immune-related adverse events.

The treatment schedule and frequency will be determined by the study protocol, focusing on the patient’s response to the therapy.

5 monitoring and evaluation

Throughout the study, the patient will be monitored for any treatment-related adverse events. The goal is to ensure that less than 50% of patients experience serious adverse events.

The patient’s response to the treatment will be assessed at 6 and 12 weeks, with additional evaluations of overall survival and the time to discontinue other immunosuppressive therapies.

6 completion of study

The study is expected to conclude by the end of 2026. The patient’s participation will end after the completion of the treatment and follow-up assessments.

The final outcomes will include the evaluation of the treatment’s safety and effectiveness, as well as the patient’s overall health status.

Who Can Join the Study?

Patients must be at least 18 years old and able to read and speak German well.
Patients need to sign a form that shows they understand the study and agree to take part. They should be willing to attend scheduled visits, follow the treatment plan, and have blood and other tests done as required by the study.
Patients should have received treatment with specific medicines called anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or a combination of these, for any type of cancer in the last 24 months. At least 30% of the patients should have a type of cancer that is not skin cancer.
Patients must show signs of immune-related adverse events (side effects from the immune system) such as:
- Colitis: Diarrhea with an increase of 4 or more stools over normal, with no improvement after 72 hours of treatment with a specific dose of a medicine like prednisolone.
- Hepatitis: Liver enzyme levels that are three times higher than normal, or three times higher than the patient’s usual levels if they were already high, and/or total bilirubin levels more than 1.5 times the normal limit, with no improvement after 72 hours of treatment with a specific dose of a medicine like prednisolone.
- Pneumonitis: Changes in lung images affecting more than one lung section or 25% of the lung, with new symptoms like cough, difficulty breathing, or chest pain, and no improvement after 72 hours of treatment with a specific dose of a medicine like prednisolone.
- Dermatitis: Skin redness or rash covering 30% or more of the body with moderate or severe symptoms, with no improvement after treatment.
Patients can have had only one additional treatment after steroid treatment before starting ECP (a specific treatment), such as infliximab for colitis.
Women who can have children must have a negative pregnancy test before starting the study. Men who are sexually active with women who can have children must use a condom during the study and for 5 months after. Patients must not donate blood, semen, or sperm during the study.
Women must not be breastfeeding.
Patients must have an ECOG performance status of 0, 1, or 2, which is a scale that measures how well they can perform daily activities.

Who Cannot Join the Study?

Patients who have not experienced immune-related adverse events (irAEs) caused by immunotherapy. These are side effects that happen when the immune system, which usually fights infections, starts attacking healthy cells in the body due to the treatment.
Patients who are not within the specified age range for the study. The study has specific age requirements that participants must meet.
Patients who belong to a vulnerable population. This means groups of people who might need special protection or care, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Upkhuvtszutoavimtypts Enxrg Ajv	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	27.07.2022

Trial locations

Investigated drugs:

Methoxsalen

Extracorporeal Photopheresis (ECP) is a therapy used in this trial to treat immune-related adverse events that do not respond to steroids. This treatment involves taking a small amount of blood from the patient, treating it with a special light, and then returning it to the patient’s body. The goal is to help manage the side effects caused by immune checkpoint inhibitor therapy, which is a type of cancer treatment.

Immune-related adverse events – These are side effects that occur when the immune system, activated by immunotherapy, mistakenly attacks healthy organs and tissues. They can affect various parts of the body, including the skin, liver, lungs, and intestines. Symptoms may vary depending on the organ involved, such as skin rashes, liver inflammation, lung inflammation, or colitis. The severity of these events can range from mild to severe, and they may develop at any time during or after treatment. The progression of these events depends on the specific immune response and the organ affected. Monitoring and managing these events is crucial to prevent complications.

Trial ID:

2024-513614-36-00

Protocol code:

1125-ECIR

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?