Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis

Eligibility Criteria

• * Age ≥ 18
• * Stage III/IV skin cancer
• * Treatment with CTLA-4 inhibitor alone or in combination with PD-1or PD-L1 blockade within the past 8 weeks
• * Clinically significant diarrhea resulting in the decision to pause immunotherapy treatment
• * Endoscopically visible colitis (Mayo 1-3) at the time of screening
• * Prior history of inflammatory colitis related to immune checkpoint inhibitors requiring treatment with \> 10 mg/day of prednisone or equivalent, or any other immunosuppressive medication
• * Concurrent immune-related Adverse Event (irAE) requiring treatment with systemic corticosteroids (dose equivalent of prednisone 10 mg/day or higher) or another systemic immune suppressing medication within the past 10 days
• * Current use of any immune suppressing biologic medication, or use within the last 4 weeks; immune stimulating medications such as checkpoint blockade are explicitly permitted
• * Current use of combination treatment with an investigation immunotherapy targeting a pathway other than PD-1 or PD-L1, concurrent chemotherapy, or targeted therapy
• * Previous adverse reaction to infliximab or corticosteroids
• * Colonic perforation or abscess present at the time of screening
• * History of Hepatitis B or C with a positive viral load, untreated mycobacterium tuberculosis, or active herpes zoster infection
• * Current bacterial infection requiring antibiotic treatment, or systemic fungal infection
• * Prior history of inflammatory bowel disease, microscopic colitis or segmental colitis associated with diverticulosis
• * Received more than 3 doses of systemic corticosteroids, or receive dsystemic corticosteroids at a dose exceeding 2mg/kg methylprednisolone or equivalent, within 72 hours prior to endoscopy