Infliximab for treating colitis caused by immune checkpoint inhibitors in skin cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of infliximab compared to steroids for treating immune checkpoint inhibitor-induced colitis in patients with stage III or IV skin cancer. It is a phase II, randomized trial that will assess how many patients achieve steroid-free disease resolution after 7 weeks of treatment. Participants will receive a CTLA-4 inhibitor, such as ipilimumab, and undergo flexible sigmoidoscopies or colonoscopies for clinical and research purposes. Blood samples will also be collected to support the study's findings.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Michael Dougan, MD, PHD — Massachusetts General Hospital
• Study coordinator: Michael Dougan, MD, PHD
• Email: Michael_Dougan@DFCI.HARVARD.EDU
• Phone: 617-726-3527

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.