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Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis — iCaD  

Colitis Clinical Trial

Official title:
Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis: a Multinational, Randomised, Open Label, Phase III Trial - The iCaD Study

Clinical Trial Summary

The goal of this clinical trial is to assess whether the early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids for severe ir-colitis/diarrhoea will reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone in patients scheduled for ICI treatment for solid tumors and untreated mCTCAE grade 2-4 diarrhoea or colitis. The main question it aims to answer is: • Can an early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone. Participants will be randomised 1:1: Arm A: All patients will receive same dose of methylprednisolone i.v. daily. Arm B: Patients allocated to Arm B will in addition receive infliximab i.v. day 1 or 2. Study patients are evaluated with blood samples, faecal samples and by sigmoidoscopy. Procedures are performed before randomisation and as part of follow up.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05947669
Study type Interventional
Source Odense University Hospital
Contact Sören K. Petersen, MD
Phone 0045 2046 5726
Email soeren.kjaer@rsyd.dk
Status Recruiting
Phase Phase 3
Start date August 22, 2023
Completion date September 2028
View Details
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