Actively Recruiting
Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis
Led by Odense University Hospital · Updated on 2023-08-24
195
Participants Needed
3
Research Sites
262 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
A
Aalborg University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assess whether the early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids for severe ir-colitis/diarrhoea will reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone in patients scheduled for ICI treatment for solid tumors and untreated mCTCAE grade 2-4 diarrhoea or colitis. The main question it aims to answer is: • Can an early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone. Participants will be randomised 1:1: Arm A: All patients will receive same dose of methylprednisolone i.v. daily. Arm B: Patients allocated to Arm B will in addition receive infliximab i.v. day 1 or 2. Study patients are evaluated with blood samples, faecal samples and by sigmoidoscopy. Procedures are performed before randomisation and as part of follow up.
CONDITIONS
Official Title
Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Untreated moderate to severe diarrhea or colitis graded 2 to 4, or persistent moderate diarrhea after loperamide treatment
- No signs of colonic perforation or infection
- Age 18 years or older
- Able to understand study purpose and procedures and have signed informed consent
- Able to read, understand, and complete questionnaires and daily patient diary
- Confirmed malignant solid tumors by histology
- Treated with immune checkpoint inhibitors within the past 12 weeks
- No other likely cause of colitis or diarrhea besides immune checkpoint inhibitors
- Prior immune checkpoint inhibitor treatment allowed
- Use of prednisolone 10 mg daily or less for non-immune-related adverse events allowed
- Required diagnostic tests for viral hepatitis and tuberculosis screening must be requested
- Women of childbearing potential must have negative pregnancy test within 72 hours before enrollment
- Patients of reproductive potential must use effective birth control during and for at least 6 months after treatment
You will not qualify if you...
- History of inflammatory bowel disease, colitis, or diarrhea requiring corticosteroids or other immunosuppressants
- History of recurrent bowel disease including symptomatic diverticulosis
- Positive testing for Clostridium difficile or other colonic infection currently
- Current bacterial infection requiring antibiotics or systemic fungal infection
- Ongoing antibiotic treatment for any reason
- Systemic corticosteroid treatment within 4 weeks before enrollment (except prednisolone 10 mg daily or less for non-immune conditions)
- Concurrent immune-related adverse events requiring immunosuppressant therapy
- Known allergy or contraindication to corticosteroids or infliximab
- History of viral hepatitis with positive viral load, untreated tuberculosis, or active herpes zoster infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Department of Oncology, Aalborg University Hospital
Aalborg, Denmark
Not Yet Recruiting
2
Department of Oncology Odense University Hospital
Odense, Denmark
Actively Recruiting
3
The Royal Marsden Hospital
London, United Kingdom
Not Yet Recruiting
Research Team
S
Sören K. Petersen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here