195
Participants
Start Date
August 22, 2023
Primary Completion Date
September 30, 2026
Study Completion Date
September 30, 2028
Infliximab
Infliximab is available in vials of 100 mg with pharmaceutical form of concentrate for solution for infusion. Participating sites will ensure availability of infliximab as part of the hospital's standard supply for use in the study.
Methylprednisolone
Methylprednisolone is available in vials of 40 mg. Methylprednisolone is a drug used for standard treatment first line for ir-colitis or diarrhoea CTCAE grade ≥ 3. Participating sites will ensure availability of methylprednisolone for use in the study as part of the hospitals standard supply.
Prednisolone
Prednisolone is available in tablets of 25 or 5 mg. Oral corticosteroids are internationally recommended as initial treatment for ir-colitis and ir-diarrhoea CTCAE grade 2 \[24-27\]. Participating sites will ensure availability of prednisolone for use in the study as part of the hospitals' standard supply.
NOT_YET_RECRUITING
Department of Oncology, Aalborg University Hospital, Aalborg
RECRUITING
Department of Oncology Odense University Hospital, Odense
NOT_YET_RECRUITING
The Royal Marsden Hospital, London
Aalborg University Hospital
OTHER
Royal Marsden NHS Foundation Trust
OTHER
Odense University Hospital
OTHER