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

Last updated: June 6, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

1/2

Condition

Inflammatory Bowel Disease

Crohn's Disease

Neoplasms

Treatment

Vedolizumab

Infliximab

Clinical Study ID

NCT04407247
2019-0276
2019-0276
NCI-2019-04986
  • Ages > 18
  • All Genders

Study Summary

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. This study may help to identify the optimal treatment strategy for immune checkpoint inhibitor-related colitis in patients with genitourinary cancer or melanoma.

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

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Vedolizumab
Phase: 1/2
Study Start date:
July 09, 2020
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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