Treating colitis in cancer patients using infliximab or vedolizumab
Treatment of Immune Checkpoint Inhibitor-Related Colitis With Infliximab or Vedolizumab: A Randomized Trial
PHASE1; PHASE2 · M.D. Anderson Cancer Center · NCT04407247
This study is testing whether two medications, infliximab and vedolizumab, can help cancer patients with colitis caused by their cancer treatment feel better and stay healthy.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | infliximab, vedolizumab, radiation, immunotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04407247 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness and safety of infliximab and vedolizumab in treating immune checkpoint inhibitor-related colitis in patients with genitourinary cancers or melanoma. Participants will be randomized to receive either infliximab or vedolizumab intravenously over a series of weeks. The study aims to assess clinical remission rates, safety, and the potential for tapering corticosteroids. Additionally, it will explore long-term outcomes and changes in immunological and microbiome profiles.
Who should consider this trial
Good fit: Ideal candidates include patients with genitourinary cancer or melanoma who have experienced significant immune-related diarrhea or colitis after receiving immune checkpoint inhibitors.
Not a fit: Patients with active gastrointestinal infections or those who do not meet the criteria for immune-related diarrhea or colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from colitis induced by cancer immunotherapy.
How similar studies have performed: Other studies have shown promise in using monoclonal antibodies for treating immune-related adverse events, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Yinghong Wang — M.D. Anderson Cancer Center
- Study coordinator: Yinghong Wang
- Email: ywang59@mdanderson.org
- Phone: 713-792-7672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colitis, Lung Non-Small Cell Carcinoma, Malignant Genitourinary System Neoplasm, Malignant Solid Neoplasm, Melanoma