Treating colitis in cancer patients using infliximab or vedolizumab

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 trial evaluates the effectiveness and safety of infliximab and vedolizumab in treating immune checkpoint inhibitor-related colitis in patients with genitourinary cancers or melanoma. Participants will be randomized to receive either infliximab or vedolizumab intravenously over a series of weeks. The study aims to assess clinical remission rates, safety, and the potential for tapering corticosteroids. Additionally, it will explore long-term outcomes and changes in immunological and microbiome profiles.

Why it matters

Who can join: the full rules

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

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Yinghong Wang — M.D. Anderson Cancer Center
• Study coordinator: Yinghong Wang
• Email: ywang59@mdanderson.org
• Phone: 713-792-7672

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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.