Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis

Launched by MASSACHUSETTS GENERAL HOSPITAL · Mar 10, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how effective and safe a medication called infliximab is for treating a specific type of inflammation in the intestines, known as immune checkpoint inhibitor colitis, in patients with advanced skin cancer (stages III and IV). The researchers want to find out how many patients who receive infliximab can stop using steroids and still see improvement in their condition after seven weeks, and they will compare this to patients who are treated with steroids.

To be eligible for this trial, participants need to be at least 18 years old and have recently been diagnosed with stage III or IV skin cancer, requiring treatment with certain cancer immunotherapies that help the immune system attack cancer. They should also be experiencing significant diarrhea that has led to a pause in their cancer treatment and show signs of colitis during a medical examination. Participants will receive either infliximab or steroids and will be monitored for their response over the study period. It’s important to note that individuals with certain medical conditions or those who have had specific prior treatments may not qualify for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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