Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis
ConditionColitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Untreated mCTCAE grade 2-4 diarrhoea or colitis, or persistent mCTCAE grade 2 diarrhoea after administration of loperamide or equivalent for mCTCAE grade ≤ 2 diarrhoea
No signs of colonic perforation or infection
Age ≥ 18
Understands the nature and purpose of the study and the study procedures and has signed informed consent
Disqualifiers
Prior history of inflammatory bowel disease, colitis, or diarrhoea requiring treatment with any corticosteroid, or any other immunosuppressant medication
Prior history of recurrent bowel disease including symptomatic diverticulosis
Current positive testing for Clostridium difficile or other colonic infection
Current bacterial infection requiring antibiotic treatment, or systemic fungal infection
Trial design
Treatments tested in this trial
- Infliximab
- Methylprednisolone
- Prednisolone
Treatment groups
195 Participants
are divided into 2 treatment groupsSponsors and collaborators
Odense University Hospital
Lead sponsor
Aalborg University Hospital
Collaborator
Royal Marsden NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov