Recruiting

Study on Infliximab and Corticosteroids for Treating Severe Colitis Caused by Immune Checkpoint Inhibitors in Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as immune checkpoint inhibitor-related colitis, which is a type of inflammation in the colon that can occur as a side effect of certain cancer treatments. The study is investigating the effectiveness and safety of a treatment plan that includes the medication Infliximab, used alongside corticosteroids, compared to using corticosteroids alone. Infliximab is a medication that helps reduce inflammation by targeting specific proteins in the body, while corticosteroids are a type of medication that helps reduce inflammation and suppress the immune system.

The purpose of the study is to determine which treatment approach is more effective in managing severe colitis or diarrhea caused by immune checkpoint inhibitors, which are drugs used in cancer therapy to help the immune system attack cancer cells. Participants in the study will receive either the combination of infliximab and corticosteroids or corticosteroids alone. The study will monitor the participants over a period of time to assess how well the treatments work in reducing the symptoms of colitis and improving the overall health of the participants.

Throughout the study, participants will be closely observed to ensure their safety and to track any changes in their condition. The study aims to provide valuable information on the best treatment options for managing colitis related to cancer therapy, ultimately helping to improve the quality of life for patients experiencing this condition. The study is expected to continue until 2029, with the goal of gathering comprehensive data on the effectiveness and safety of the treatment options being tested.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
A pregnancy test is required for women of childbearing potential within 72 hours prior to registration.
Participants must understand the study's nature and purpose and sign an informed consent form.
Step 2
Randomization
Participants are randomly assigned to one of two groups: one receiving corticosteroid treatment alone, and the other receiving a combination of infliximab and corticosteroid treatment.
Step 3
Treatment phase
Participants in the corticosteroid group receive prednisolone orally. The dosage and frequency are determined by the study protocol.
Participants in the combination group receive infliximab intravenously, along with oral prednisolone. The dosage and frequency are determined by the study protocol.
The treatment phase lasts for up to seven weeks, with regular monitoring of symptoms and health status.
Step 4
Monitoring and follow-up
Participants are monitored for any changes in symptoms, particularly the severity of colitis or diarrhea.
Regular assessments are conducted to evaluate the effectiveness of the treatment and any side effects.
Quality of life is assessed using specific questionnaires at baseline, 3, 12, 24, and 52 weeks after randomization.
Step 5
Completion and evaluation
At the end of the study period, participants undergo a final evaluation to assess the overall effectiveness and safety of the treatment.
Participants are informed about the study's findings and any implications for their future care.

Who can join the trial?

13 criteria

Must have untreated or persistent diarrhea or colitis of a certain severity. Diarrhea is frequent, loose, or watery bowel movements. Colitis is inflammation of the colon.
Can use up to 10 mg of prednisolone daily for conditions not related to immune reactions. Prednisolone is a type of steroid medication.
Must have tests done to check for viral liver infection and tuberculosis, but results are not needed before joining the study.
Women of childbearing potential must have a negative pregnancy test within 72 hours before joining. This includes women who can become pregnant, even if they haven't had a period for 12 months due to certain conditions.
Participants who can have children should use effective birth control during the study and for at least 6 months after the last treatment. Effective methods include hormonal contraception, IUDs, sterilization, or abstinence.
No signs of a hole in the colon or infection.
Must be 18 years or older.
Must understand the study and its procedures and have signed a consent form.
Must be able to read, understand, and complete study questionnaires and a daily diary.
Must have a confirmed diagnosis of a malignant solid tumor. This means a type of cancer that forms in solid organs or tissues.
Must have been treated with immune checkpoint inhibitors in the past 12 weeks. These are drugs that help the immune system fight cancer.
No other treatments, like laxatives, should be causing the colitis or diarrhea.
Previous treatment with immune checkpoint inhibitors is allowed.

Who cannot join the trial?

8 criteria

Patients who have a different type of colitis not related to immune checkpoint inhibitors cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who are not able to follow the study procedures or take the study medications cannot participate.
Patients with other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had a recent infection or illness that could affect the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Aalborg University Hospital
Aalborg, Denmark
Verified
Herlev Hospital
Herlev, Denmark
Verified
Odense University Hospital
Odense, Denmark

Trial locations

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Investigated drugs

Infliximab
is a medication used in this trial to help reduce inflammation in the body. It is often used to treat conditions where the immune system is overactive, such as certain types of arthritis and inflammatory bowel disease. In this study, infliximab is being tested to see if it can help treat colitis, which is inflammation of the colon, caused by immune checkpoint inhibitors, a type of cancer treatment. The goal is to see if infliximab can effectively reduce the inflammation and symptoms of colitis when used alongside another medication called corticosteroids.
Corticosteroids
are a type of medication that helps reduce inflammation and suppress the immune system. They are commonly used to treat a variety of conditions, including allergies, asthma, and autoimmune diseases. In this trial, corticosteroids are being used to help manage the inflammation and symptoms of colitis caused by immune checkpoint inhibitors. The study aims to compare the effectiveness of using corticosteroids alone versus using them in combination with infliximab to see which approach is more effective in treating the condition.

What is already known about the treatment

Infliximab – Infliximab is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently being studied in a phase III clinical trial for its effectiveness and safety in treating colitis caused by immune checkpoint inhibitors, which are drugs used in cancer therapy. The main therapeutic use of infliximab in this context is to reduce inflammation in the colon. At the molecular level, infliximab works by blocking a protein called tumor necrosis factor-alpha (TNF-alpha), which plays a key role in causing inflammation. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

Investigated diseases

Immune Checkpoint Inhibitor Related Colitis – This condition occurs as a side effect of cancer treatment with immune checkpoint inhibitors, which are drugs that help the immune system attack cancer cells. The disease involves inflammation of the colon, leading to symptoms such as diarrhea, abdominal pain, and cramping. The inflammation is caused by the immune system mistakenly attacking the cells of the colon. As the condition progresses, the severity of symptoms can increase, potentially leading to dehydration and electrolyte imbalances. The inflammation can vary in intensity, and in some cases, it may become chronic if not managed properly. The progression of symptoms can fluctuate, with periods of improvement and worsening, depending on the immune response and treatment interventions.