Clinical Trial Finder

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

PRIMARY OBJECTIVES:

• I. To compare the efficacy of infliximab and vedolizumab for clinical remission/response of immune-related diarrhea and/or colitis.

• II. To assess the safety and tolerability of the treatment for immune-mediated diarrhea and/or colitis.

SECONDARY OBJECTIVES:

• I. To assess the efficacy of infliximab and vedolizumab for clinical remission/response of IMC at 4 weeks.

• II. To assess the success of corticosteroid tapering.

• III. To measure the recurrence rate after corticosteroid taper.

EXPLORATORY OBJECTIVES:

• I. To assess the efficacy of infliximab and vedolizumab to achieve endoscopic remission of immune-related diarrhea and/or colitis.

• II. To assess the efficacy of infliximab and vedolizumab to achieve histological remission of immune-related diarrhea and/or colitis.

• III. To assess the time duration to achieve the clinical remission/response.

• IV. To assess the long term outcome of cancer.

• V. To assess immunological, molecular and microbiome changes in tissue/blood/stool.

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive infliximab intravenously (IV) over 1 hour once at week 0, 2, 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive vedolizumab IV over 1 hour once at week 0, 2, 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity. Patients are followed up weekly for 1 month and then at 2 and 3 months after the treatment.

Arms

Active Comparator: Arm I (infliximab)

Patients receive infliximab IV over 1 hour once at week 0, 2, 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity.

Experimental: Arm II (vedolizumab)

Patients receive vedolizumab IV over 1 hour at week 0, 2, 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity.

Interventions

Biological: - Infliximab

Given IV

Biological: - Vedolizumab

Given IV