Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Phase 1/2 Trial to determine the safety and efficacy of Extracorporeal photopheresis as treatment for steriod-refractory immune related adverse events after immune checkpoint inhibitor therapy - ECIR

This research study is investigating a treatment called Extracorporeal Photopheresis, or ECP, for people who have experienced difficult side effects from immunotherapy cancer treatments. Immunotherapy helps your body fight cancer, but sometimes it can cause your immune system to overreact and attack healthy parts of your body. These side effects can include inflammation in the gut (colitis), lungs (pneumonitis), liver (hepatitis), or skin (dermatitis). The main goal of this study is to check the safety of ECP for these side effects. Researchers want to find out how many participants experience any treatment-related problems, especially serious ones. If serious problems happen in 50% or fewer of the participants, that would be considered a positive safety result. The study will also look at how well ECP helps improve these conditions.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Medical Center - University Of Freiburg

Enrolment target

Start

02 Aug 2024

What is this study about?

This study is looking at a new way to help people who have developed side effects after receiving a type of cancer treatment called immunotherapy. Immunotherapy is a powerful medicine that helps your own body's immune system fight cancer. However, sometimes the immune system can become too active and attack healthy parts of your body, leading to uncomfortable and sometimes serious side effects. These problems can include inflammation in the bowel (colitis), lungs (pneumonitis), liver (hepatitis), or skin (dermatitis).

The treatment being studied is called Extracorporeal Photopheresis, or ECP. This is a special treatment where a small amount of your blood is taken out, treated with a medicine and a special light, and then returned to your body. The idea is that this process can help to calm down your overactive immune system without using more strong medications like steroids, which might not be working well for you.

Researchers want to carefully check how safe ECP is for people with these side effects. They will closely watch for any side effects related to the ECP treatment itself. They also want to see if ECP helps improve the inflammation in the gut, lungs, liver, or skin. This study is important because it could offer a new option for people struggling with these particular side effects from their cancer treatment.

Key takeaways

The study investigates a treatment called ECP for serious side effects from cancer immunotherapy.
It focuses on inflammation in the gut, lungs, liver, or skin that hasn't responded to steroids.
The main goals are to check the safety of ECP and see how well it improves these conditions.
ECP involves treating your blood outside your body and then returning it.
Participation requires regular clinic visits for treatment and monitoring.
You have the right to leave the study at any time.

Who may be eligible?

This study is for adults aged 18 and over, of any gender. To be considered, you must have developed certain side effects in your gut, lungs, liver, or skin after receiving specific cancer treatments known as immune checkpoint inhibitors.

Importantly, your doctors must have tried giving you steroid medicines for these side effects, and those steroids must not have worked well enough, or you might not have been able to tolerate them. This means your side effects are considered 'steroid-refractory'.

There will be other detailed medical checks to make sure this study is right for you and safe for you to take part. Your medical team will go through all of these specific requirements with you.

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 old or older?
Have you developed inflammation in your gut, lungs, liver, or skin?
Did these problems start after you had immunotherapy for cancer?
Have steroid medicines not worked well enough to control these side effects for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the ECP treatment. This involves having some of your blood taken out, treated with a special light and medicine, and then returned to you. This process is similar to dialysis or donating blood, though it’s a bit more involved.

Throughout the study, you would have regular visits to the clinic for your ECP treatments and check-ups. These check-ups will include physical examinations, blood tests, and possibly other tests like scans (e.g., to check your lungs or liver) to see how your body is responding to the treatment and to monitor for any side effects. Researchers will also be looking at how long it takes for your condition to improve and how long any improvement lasts.

The study will also track your survival over one year after your ECP treatment finishes and see if you can reduce or stop other medicines you might be taking to control your immune system. The overall duration of your involvement could vary depending on your response and follow-up requirements, but typically involves a period of treatment with follow-up for some months afterwards.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that ECP might help to reduce the inflammation and side effects you're experiencing from your cancer treatment, especially if other treatments haven't worked well. However, there's no guarantee that ECP will work for you, and it's also possible you could experience side effects from the ECP treatment itself, similar to other blood-based procedures. These might include discomfort, bruising, infection at the needle site, or feeling tired. The research team will explain all known risks to you. Remember, choosing to participate is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is immunotherapy and why did it cause side effects?

Immunotherapy is a cancer treatment that boosts your body's immune system to fight cancer cells. Sometimes, this boost can make your immune system too active, causing it to attack healthy cells, leading to inflammation in different body parts.

What does Extracorporeal Photopheresis (ECP) involve?

ECP is a treatment where a small amount of your blood is temporarily taken out, treated with a special medicine and UV light, and then returned to your body. This process aims to calm down your overactive immune system.

Why is this study only for people whose side effects haven't responded to steroids?

This study focuses on people who haven't found enough relief from steroid medications, which are a common first treatment for these side effects. Researchers hope ECP can be an effective alternative when steroids don't work well.

Will I still receive my regular cancer treatment during the study?

Your regular cancer treatment plan will be discussed with the study team. The aim is to manage these side effects while ensuring your overall cancer care continues appropriately. This will be explained in detail.

How long will I be involved in the study?

The study involves a period of ECP treatments and then follow-up checks. Your exact timeline will depend on your condition and response, but researchers will monitor your progress and health for up to a year after ECP treatment ends.