Short summary

Immune checkpoint inhibitors (ICIs) improve cancer survival but frequently cause immune-related adverse events (irAEs), particularly colitis. This prospective cohort study aims to investigate ICI-induced changes in immune cells and gut microbiota and their relation to irAE development and patient quality of life during combination ICI therapy in melanoma.

Rationale

ICIs have revolutionised cancer treatment but are often limited by irAEs, including colitis. The underlying mechanisms remain poorly understood. This study investigates immune and microbial changes during combination ICI treatment in melanoma, aiming to identify predictors of irAE development and explore impacts on patient-reported quality of life.

Description of the cohort

Melanoma patients scheduled for treatment with immune checkpoint inhibitor combination therapy. Restricted to Department of Oncology, OUH.

Data and biological material

Blood- and feacal samples are prospectively collected. Further, two sigmoideoscopies are performed including intestinal biopsies. Finally, HRQoL is collected prospectively.

Collaborating researchers and departments

Department of Oncology, OUH

• Christina Ruhlmann
• Lars Bastholt

Department of gastroenterology, OUH

• Jens Kjeldsen