Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients

Launched by M.D. ANDERSON CANCER CENTER · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to see if a medication called ustekinumab can help control diarrhea and colitis (inflammation of the intestines) that some cancer patients experience as a side effect of their cancer treatments known as immune checkpoint inhibitors (ICIs). The study aims to find out if ustekinumab can provide relief for patients who have moderate to severe cases of these gastrointestinal issues.

To participate in the trial, patients need to be 18 years or older and have been treated with an ICI therapy that caused them to develop at least grade 2 diarrhea or colitis within the last 45 days. They also need to have a solid tumor diagnosis and be cleared of any active gastrointestinal infections. Participants can expect to be monitored closely by medical professionals throughout the study to assess how well the treatment works and to ensure their safety. It’s important for potential participants to discuss any prior treatments and health conditions with their doctor to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who receive any type of ICI therapy
• • 2. Patients with ≥ grade 2 immune-related diarrhea and/or colitis according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 45 days prior to enrollment in study
• • 3. Patients with ability to understand and willingness to sign informed consent
• • 4. Patients with a diagnosis of any type of solid tumors on ICI systemic therapy
• • 5. No concern for active concomitant GI infection for immune-related diarrhea and/or colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation
• • 6. Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment
• • 7. Concurrent or prior cancer therapy (non-checkpoint inhibitors) that are not deemed as a significant contributor of the GI adverse event can be allowed in the study.
• Exclusion Criteria:
• • 1. Patients younger than 18 years of age
• • 2. Patients with persistent gastrointestinal infection confirmed with positive testing despite completing 5 days of antibiotics
• • 3. Patients on concurrent immunosuppressive therapies other than what will be given for colitis
• • 4. Patients with history of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation
• • 5. Pregnant and breastfeeding women
• • 6. Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to enrollment in study
• • 7. Patients who develop concurrent non-GI toxicity at the time of study treatment initiation
• • 8. Patients have already received other biologic treatment for IMDC such as infliximab, vedolizumab