Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma
NCT ID: NCT04407247
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
47 participants
INTERVENTIONAL
2020-07-09
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Infliximab
Given IV
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.
Vedolizumab
Given IV
Interventions
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Infliximab
Given IV
Vedolizumab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Yinghong Wang
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2019-04986
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-0276
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0276
Identifier Type: -
Identifier Source: org_study_id