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Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Sponsor: Massachusetts General Hospital
Summary
The goal of this clinical trial is to compare the safety and effectiveness of infliximab compared to steroids for the treatment of immune checkpoint inhibitor-induced colitis (ICI colitis) in patients with stage III/IV skin cancer. The main questions this study aims to answer are: * How many patients treated with infliximab experience steroid-free disease resolution after 7 weeks? * How many patients treated with steroids experience steroid-free disease resolution after 7 weeks?
Official title: Phase II Study of Infliximab for the Treatment of Immune Checkpoint Inhibitor Colitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2020-08-31
Completion Date
2030-06-30
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
Infliximab
Infusion
Methylprednisolone
Infusion
Prednisone
Orally
Locations (2)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States