Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis

Last updated: January 27, 2026
Sponsor: Massachusetts General Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Skin Cancer

Adverse Effects, Drugs

Melanoma

Treatment

Prednisone

Methylprednisolone

Infliximab

Clinical Study ID

NCT04305145
19-763
  • Ages > 18
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18

  • Stage III/IV skin cancer

  • Treatment with CTLA-4 inhibitor alone or in combination with PD-1or PD-L1 blockadewithin the past 8 weeks

  • Clinically significant diarrhea resulting in the decision to pause immunotherapytreatment

  • Endoscopically visible colitis (Mayo 1-3) at the time of screening

Exclusion

Exclusion Criteria:

  • Prior history of inflammatory colitis related to immune checkpoint inhibitorsrequiring treatment with > 10 mg/day of prednisone or equivalent, or any otherimmunosuppressive medication

  • Concurrent immune-related Adverse Event (irAE) requiring treatment with systemiccorticosteroids (dose equivalent of prednisone 10 mg/day or higher) or anothersystemic immune suppressing medication within the past 10 days

  • Current use of any immune suppressing biologic medication, or use within the last 4weeks; immune stimulating medications such as checkpoint blockade are explicitlypermitted

  • Current use of combination treatment with an investigation immunotherapy targeting apathway 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 mycobacteriumtuberculosis, or active herpes zoster infection

  • Current bacterial infection requiring antibiotic treatment, or systemic fungalinfection

  • Prior history of inflammatory bowel disease, microscopic colitis or segmentalcolitis associated with diverticulosis

  • Received more than 3 doses of systemic corticosteroids, or receive dsystemiccorticosteroids at a dose exceeding 2mg/kg methylprednisolone or equivalent, within 72 hours prior to endoscopy

Study Design

Total Participants: 42
Treatment Group(s): 3
Primary Treatment: Prednisone
Phase: 2
Study Start date:
August 31, 2020
Estimated Completion Date:
June 30, 2030

Study Description

This is a phase II, randomized, signal-detection trial to evaluate the efficacy and safety of the drugs infliximab, methylprednisolone, and prednisone to manage the side of effect of colitis caused by immune checkpoint inhibitors (ICIs) that target a protein called CTLA-4. An example of one of these ICIs is ipilimumab, which has been approved by the FDA to treat metastatic melanoma.

The names of the treatments involved in this study are:

  • Infliximab

  • Methylprednisolone

  • Prednisone

The FDA has approved infliximab, methylprednisolone, and prednisone to treat many conditions affecting the immune system, including colitis.

Participants will receive a CTLA-4 inhibitor, like ipilimumab, and any other cancer treatments as part of their regular care for stage III/IV skin cancer at the discretion of treating oncologist.

Participants who enroll in this study will undergo one or more flexible sigmoidoscopies or colonoscopies as part of their clinical care. The first of these procedures would occur at the time of study enrollment, and the second may occur after several weeks of treatment at the discretion of the study doctor. During these procedures, biopsies will be collected for clinical purposes as well as for research purposes. Blood will also be collected for research at the time of enrollment and at the time of study completion. Any extra samples for research would only be collected if it is safe for the participant.

Participants will also complete weekly follow-ups either over the phone or in-person that may last about 10 minutes. During these visits, participants will be asked about any new symptoms or changes in their health, their medications, and their GI symptoms. Blood for research may be collected at one or more of these visits if it coincides with a scheduled clinical blood draw.

Participants are expected to be on study treatment for approximately 7 weeks. Once participants complete the study treatment, the study team will review their medical records every 6 months for any changes in their health.

It is expected that about 42 people will take part in this research study.

Connect with a study center

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Massachusetts General Hospital Cancer Center

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

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