Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis

Inclusion Criteria * 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 * Is able to read, understand, and complete questionnaires and daily components of the patient Diary for the study period * Histologically confirmed malignant solid tumours * Treatment with immune checkpoint inhibitors (anti-CTLA-4, anti-PD-1 or anti-PD-L1) within the past 12 weeks. Immune checkpoint inhibitors can be administered as single agents or as combination therapy with anti-CTLA-4 and anti-PD-1 * No probability of a concomitant treatment (e.g. laxatives) other than the immune checkpoint inhibitor being the causal drug for the colitis or diarrhoea * Prior treatment with immune checkpoint inhibitors is allowed * Usage of prednisolone ≤ 10 mg daily for non irAE is allowed * Diagnostic work up including screening for viral hepatic infection and QuantiFERON-TB for mycobacterium tuberculosis must be requisitioned but will not need to be reported prior to study enrolment * Women of child bearing potential must have a negative serum (preferred) or urine pregnancy test within 72 hours prior to registration. * Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females…