Evaluating Early Use of Infliximab with Corticosteroids for Treating Immune Checkpoint Inhibitor Induced Colitis in Adults with Solid Tumors A Phase III Randomized Trial

What this Trial Is About

This trial studies patients with severe immune checkpoint inhibitor-induced colitis or diarrhoea, conditions caused by cancer treatments called immune checkpoint inhibitors used for solid tumors. It aims to find out if starting a biological drug called infliximab early, along with corticosteroids, helps reduce the duration of these symptoms compared to using corticosteroids alone. The study is a Phase III randomized trial involving patients with moderate to severe ir-colitis or diarrhoea. Participants are randomly assigned to one of two groups. One group receives intravenous methylprednisolone daily, adjusted by body weight, starting on Day 1 until symptoms improve to mild or better, then switching to oral prednisolone. The other group receives the same corticosteroid treatment plus infliximab infusion on Day 1 or 2, with a possible second dose if symptoms persist. Patients are hospitalized initially or managed as outpatients if requirements are met. During the study, patients undergo blood and stool sample collection and sigmoidoscopy before randomization and during follow-up. Researchers evaluate the time it takes to reduce symptoms to mild or less within seven weeks, along with other measures like quality of life, corticosteroid exposure, need for additional immunosuppressants, and adverse events. The total study period includes close monitoring up to 52 weeks for quality of life assessments and safety.

Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis