Status:
ACTIVE_NOT_RECRUITING
Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colitis
Lung Non-Small Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04407247
Start Date
July 9 2020
End Date
December 31 2027
Last Update
December 23 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030