Short summary

Immune checkpoint inhibitor induced colitis (ir-colitis) is a commen adverse event. The evidence for treating ir-colitis is based upon experience from genuine autoimmune colitis. In this phase III study we want to explore the role of early administration of biological treatment (TNF alpha inhibitor) in management of ir-colitis hypothesing the cumulative use of corticosteroids will be reduced when using biological treatment.

Rationale

Immune checkpoint inhibitors (ICIs) have improved survival of patients with a wide range of cancer diseases. This benefit comes with a risk of immune related adverse events (irAE). Colitis and diarrhoea are among frequently occurring irAEs and these conditions can progress severely and even fatal. Treatment of ir-colitis and ir-diarrhoea is empirically based using corticosteroids, and if no response after three days, patients will be evaluated for biological treatment. There is an urgent need for evidence based and optimised treatment.

Description of the cohort

Subjects treated with ICIs at the Department of Oncology, OUH and devolveloped ir-colitis. The trial is expected to include participants at other Oncological Departments nationally as well as internationally.

Data and biological material

Multiple data sources is collected in the study database including ir-colitis grading scales, blood- and fecal samples, endoscopic and PET/CT scans. PROMs are collected as well including HRQoL questionaires.

Collaborating researchers and departments

Department of gastroenterology, OUH

• Prof. Jens Kjeldsen