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ACTIVE NOT RECRUITING
NCT04305145
PHASE2

Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Infliximab

Infusion

DRUG

Methylprednisolone

Infusion

DRUG

Prednisone

Orally

Locations (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States