Early Vedolizumab As First-Line for Immune-Related Colitis Therapy Trial
Status:
NOT_YET_RECRUITING
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
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
Phase:
PHASE2
Details
Lead Sponsor:
Shilpa Grover, MD, MPH
Collaborators:
Dana-Farber/Brigham and Women's Cancer Center Takeda
Treatments:
Injections Methylprednisolone Prednisone Trimethoprim, Sulfamethoxazole Drug Combination vedolizumab