Phase
Condition
Neoplasms
Melanoma
Inflammatory Bowel Disease
Treatment
Vedolizumab
Infliximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 tothe Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 45days 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/orcolitis work up at the time of protocol therapy initiation as confirmed by stooltests or as per the treating physician based on clinical presentation
Patient who has been cleared for enrollment by Infectious Diseases consultant ortreating physician if positive infection workup or screening tests (e.g. lifelongpositive T-spot due to BCG inoculation, chronic colonization) prior to initiation ofdiarrhea/colitis treatment
Exclusion
Exclusion Criteria:
Patients younger than 18 years of age
Patients with persistent gastrointestinal infection confirmed with positive testingdespite completing 5 days of antibiotics
Patients are on concurrent immunosuppressive therapies other than what will be givenfor colitis
Patients with preexisting activehistory of inflammatory bowel disease and/orradiation enterocolitis with active disease status at the time of study treatmentinitiation
Pregnant and breastfeeding women, and
Women of child-bearing potential who have positive urine or serum pregnancy test orrefuse to do pregnancy test unless last menstrual cycle was > 1 year prior toconsent and/ or clear documentation states that patient is peri- or post-menopausalor 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 treatmentinitiation
Study Design
Study Description
Connect with a study center
M D Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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