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Study identifier: NCT06841705 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial

Condition: Immune Checkpoint Inhibitor-Related Colitis  ·  Sponsor: Shilpa Grover, MD, MPH

PhasePhase 2
Planned participants80
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

Talk to the study team

Shilpa Grover, MD, MPH  ·  6177326389  ·  sgrover@bwh.harvard.edu

Seonyoung Goo  ·  sgoo@bwh.harvard.edu

Always discuss trial participation with your own doctor first.

Locations (2)

Brigham and Women's HospitalBoston, Massachusetts, United StatesRecruiting
Dana Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06841705