Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis (NCT04305145) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
United States42 participantsStarted 2020-08-31
Plain-language 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?
Who can participate
Age range18 Years
SexALL
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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 disea…