Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma

Launched by M.D. ANDERSON CANCER CENTER · May 27, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring how effective and safe two treatments, infliximab and vedolizumab, are for patients experiencing inflammation of the colon (called colitis) due to immune checkpoint inhibitors, which are a type of cancer treatment. The trial specifically focuses on patients with certain cancers, including genitourinary cancer and melanoma. Researchers hope to find the best way to manage this colitis, which can be a side effect of the immune therapy.

To be eligible for the trial, participants need to be at least 18 years old and have received immune checkpoint inhibitor therapy. They should have experienced moderate to severe diarrhea or colitis recently, but they must be free from any active gastrointestinal infections. Participants can expect to receive either infliximab or vedolizumab and will be closely monitored for side effects and treatment effectiveness. The trial is currently recruiting patients, and it aims to provide valuable information that could improve care for those affected by immune-related colitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who receive any type of immune checkpoint inhibitor (ICI) therapy
• • Patients with peak 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 initiation of study treatment (infliximab/ vedolizumab)
• • Patients with ability to understand and willingness to sign informed consent
• • Patients with genitourinary cancer or melanoma or non-small cell lung cancer
• • 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
• • 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
• Exclusion Criteria:
• • Patients younger than 18 years of age
• • Patients with persistent gastrointestinal infection confirmed with positive testing despite completing 5 days of antibiotics
• • Patients are on concurrent immunosuppressive therapies other than what will be given for colitis
• • Patients with preexisting activehistory of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation
• • Pregnant and breastfeeding women, and
• • 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 initiation of study treatment
• • Patients who develop concurrent non-GI toxicity at the time of study treatment initiation