RecruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis

This clinical trial is for people with bowel inflammation (colitis) or severe diarrhoea caused by certain cancer treatments called immune checkpoint inhibitors. Researchers want to find out if adding a drug called infliximab to the usual steroid treatment can help people get better more quickly. Participants will be split into two groups by chance: one group will receive standard steroid treatment, and the other will receive steroids plus infliximab. The study will involve blood and stool samples, and a camera test of the bowel (sigmoidoscopy). This research aims to improve how we manage side effects from important cancer therapies.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Odense University Hospital

Enrolment target

195

Start

22 Aug 2023

Estimated completion

01 Sep 2028

Colitis

What is this study about?

This study is investigating a common side effect of modern cancer treatments called immune checkpoint inhibitors. These powerful medicines help your body's immune system fight cancer, but sometimes they can also cause inflammation in other parts of the body, including the bowel. This can lead to severe diarrhoea or a condition called colitis, which is inflammation of the large intestine.

The main aim of this trial is to see if adding an extra medicine, infliximab, to the standard steroid treatment can help people recover faster from this bowel inflammation. Infliximab is a type of 'biological' drug that works by blocking a substance in the body called TNF-alpha, which plays a role in inflammation. The researchers want to know if starting infliximab early, alongside steroids, is better than using steroids alone.

Participants in this study will be randomly assigned to one of two groups. Both groups will receive a steroid medicine called methylprednisolone. One group will also receive infliximab. By comparing these two groups, doctors hope to learn if this combination treatment can reduce the severity and duration of bowel problems caused by cancer immunotherapy. Finding better ways to manage these side effects is important so that more people can continue their cancer treatment effectively.

Key takeaways

Tests a new approach for bowel inflammation (colitis) from cancer treatment.
Compares steroids plus infliximab versus steroids alone.
Aims to see if infliximab helps symptoms get better faster.
Involves blood/stool samples and a camera test of the bowel.
Participation includes filling in a daily diary.
You have a 50/50 chance of getting infliximab in addition to steroids.

Who may be eligible?

To join this study, you must be an adult aged 18 or older with bowel inflammation or severe diarrhoea that started recently due to cancer treatment with immune checkpoint inhibitors. Your doctor will need to confirm that your symptoms are of a certain severity and that there are no signs of a serious tear in your bowel or an infection. You should also be able to understand the study and complete questionnaires.

It's important that your bowels started acting up within 12 weeks of starting your immune checkpoint inhibitor treatment. You can't join if a different medicine like a laxative is likely causing your bowel issues. Women who could become pregnant will need a negative pregnancy test and agree to use effective birth control during the study.

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?
Do you have severe diarrhoea or bowel inflammation from cancer treatment?
Did these symptoms start within the last 12 weeks of your cancer treatment?
Are you able to understand the study information and fill in questionnaires?
Are you a woman who could become pregnant and willing to use birth control during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups. Both groups will receive a steroid medicine called methylprednisolone, given through a drip into your vein every day. If you are in the second group, you will also receive infliximab as a drip on the first or second day of the study. You will have regular check-ups which include providing blood and stool samples. You will also have a procedure called a sigmoidoscopy, where a tiny camera is used to look at your bowel, at the start of the study and as part of your follow-up appointments. You will be asked to fill in a diary each day. The study will monitor how quickly your bowel symptoms improve.

Potential risks and benefits

Participating in this study might offer the benefit of potentially quicker relief from your bowel symptoms compared to standard treatment alone. However, like all medicines, infliximab and steroids have potential side effects, which your doctor will discuss with you. There's also a chance you might not receive the infliximab. Your comfort and safety are a priority, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

Department of Oncology, Aalborg University Hospital
Verified postcode
Aalborg, Denmark· Not yet recruiting
Department of Oncology Odense University Hospital
Verified postcode
Odense, Denmark· Recruiting
The Royal Marsden Hospital
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is 'colitis'?

Colitis is inflammation of your large bowel (colon), which can cause tummy pain, cramping, and diarrhoea.

What are immune checkpoint inhibitors?

These are a type of cancer medicine that helps your body's immune system fight cancer cells more effectively.

What is infliximab?

Infliximab is a medicine that reduces inflammation by blocking a protein in your body called TNF-alpha.

Will I definitely get infliximab if I join?

No, you'll be assigned by chance to either receive infliximab plus steroids, or steroids alone. It's like flipping a coin.

What is a sigmoidoscopy?

It's a procedure where a thin, flexible tube with a camera on the end is gently inserted into your back passage to look at the lower part of your bowel.

How to find out more

Sören K. Petersen, MD

soeren.kjaer@rsyd.dk 0045 2046 5726 Official trial record

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