Condition: Immune Checkpoint Inhibitor-Related Colitis · Sponsor: Shilpa Grover, MD, MPH
The goal of this clinical trial is to compare the effectiveness and safety of Vedolizumab with a short course of steroids compared to standard course of steroids for the treatment of immune checkpoint inhibitor colitis (ICI colitis) in adults. The main questions it aims to answer are: * How many patients treated with Vedolizumab and a short course of steroids experience resolution of colitis at 8 weeks. * How many patients treated with a standard course of steroids experience resolution of colitis at 8 weeks. Participants will: Recieve 3 doses of Vedolizumab or a placebo (a look-alike substance that contains no drug) infusions over 6 weeks Receive intravenous Medrol daily for 3 days Receive Prednisone daily for 7 days Receive Prednisone or placebo taper daily Receive Sulfamethoxazole-Trimethoprim or placebo taper daily Weekly checkups and periodic tests
This description comes directly from the study's public registry record.
Shilpa Grover, MD, MPH · 6177326389 · sgrover@bwh.harvard.edu
Seonyoung Goo · sgoo@bwh.harvard.edu
Always discuss trial participation with your own doctor first.
| Brigham and Women's Hospital | Boston, Massachusetts, United States | Recruiting |
| Dana Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06841705