Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis

PHASE3RecruitingINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

August 22, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2028

Conditions
Colitis
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (3)

Unknown

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

All Listed Sponsors
collaborator

Aalborg University Hospital

OTHER

collaborator

Royal Marsden NHS Foundation Trust

OTHER

lead

Odense University Hospital

OTHER