Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis

Running, not enrolling · Phase 2

Conditions studied: Melanoma Stage III, Melanoma Stage IV, Skin Cancer Stage III, Skin Cancer Stage IV, Drug-Induced Colitis, Drug Toxicity, Immune-related Adverse Event

In brief

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?

Key facts

Study ID

NCT04305145

Run by

Massachusetts General Hospital

People needed

42

Starts

2020-08-31

Expected to finish

2030-06-30

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18
• Stage III/IV skin cancer
• Treatment with CTLA-4 inhibitor alone or in combination with PD-1or PD-L1 blockade within the past 8 weeks
• Clinically significant diarrhea resulting in the decision to pause immunotherapy treatment
• Endoscopically visible colitis (Mayo 1-3) at the time of screening

You may not qualify if…

• Prior history of inflammatory colitis related to immune checkpoint inhibitors requiring treatment with > 10 mg/day of prednisone or equivalent, or any other immunosuppressive medication
• Concurrent immune-related Adverse Event (irAE) requiring treatment with systemic corticosteroids (dose equivalent of prednisone 10 mg/day or higher) or another systemic immune suppressing medication within the past 10 days
• Current use of any immune suppressing biologic medication, or use within the last 4 weeks; immune stimulating medications such as checkpoint blockade are explicitly permitted
• Current use of combination treatment with an investigation immunotherapy targeting a pathway other than PD-1 or PD-L1, concurrent chemotherapy, or targeted therapy
• Previous adverse reaction to infliximab or corticosteroids
• Colonic perforation or abscess present at the time of screening
• History of Hepatitis B or C with a positive viral load, untreated mycobacterium tuberculosis, or active herpes zoster infection
• Current bacterial infection requiring antibiotic treatment, or systemic fungal infection
• Prior history of inflammatory bowel disease, microscopic colitis or segmental colitis associated with diverticulosis
• Received more than 3 doses of systemic corticosteroids, or receive dsystemic corticosteroids at a dose exceeding 2mg/kg methylprednisolone or equivalent, within 72 hours prior to endoscopy

Where it is running

• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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