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

Status: active

This phase I/II trial studies the side effects of infliximab and vedolizumab and to see how well they work in treating inflammation of the colon (colitis) caused by immune checkpoint inhibitor therapy in patients with cancer of the genital and urinary organs (genitourinary) or melanoma. Monoclonal antibodies, such as infliximab or vedolizumab, may help to treat immunotherapy induced colitis/diarrhea and may manage diarrhea symptoms or intestinal inflammation. This study may help to identify the optimal treatment strategy for immune checkpoint inhibitor-related colitis in patients with genitourinary cancer or melanoma.

Inclusion Criteria

Patients who receive any type of immune checkpoint inhibitor (ICI) therapy
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
Patients with ability to understand and willingness to sign informed consent
Patients with a diagnosis of any type of genitourinary, lung, ovarian, uterine, cervical, breast, gastrointestinal, head & neck (tonsil, tongue, parotid, mandibular) malignancies or melanoma
No concern for active concomitant gastrointestinal (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 Bacillus Calmette-Guerin [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 history of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation
Pregnant and breastfeeding women
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 immune-related diarrhea and/or colitis 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/colitis.

II. To assess the efficacy of infliximab and vedolizumab to achieve histological remission of immune-related diarrhea/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 30-60 minutes during weeks 0, 2, and 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo an endoscopy (colonoscopy or sigmoidoscopy) with biopsy at baseline and again at 8 weeks if the baseline results showed confirmation of colitis. Patients may also undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans periodically throughout the study. Additionally, patients undergo stool sample collection and may optionally undergo blood sample collection throughout the study.

ARM II: Patients receive vedolizumab IV over 30-60 minutes during weeks 0, 2, and 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo an endoscopy (colonoscopy or sigmoidoscopy) with biopsy at baseline and again at 8 weeks if the baseline results showed confirmation of colitis. Patients may also undergo MRI or CT scans periodically throughout the study. Additionally, patients undergo stool sample collection and may optionally undergo blood sample collection throughout the study.

Upon completion of study treatment, patients are followed up weekly for 1 month and then at 2 and 3 months.

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

Inclusion Criteria

Exclusion Criteria

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Texas

Houston

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

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