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

Recruiting Phase 2 Interventional Study
Immune Checkpoint Inhibitor-Related Colitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Shilpa Grover, MD, MPH · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * In order to participate in the study, a patient must meet all the following inclusion criteria: * Age ≥18 years. * Treatment with an ICI for cancer within the past 8 weeks. * Confirmed endoscopic/histologic diagnosis of ICI colitis. * Grade 2-3 diarrhea by Common Terminology C…
Contacts

Shilpa Grover, MD, MPH

6177326389

sgrover@bwh.harvard.edu

CONTACT

Seonyoung Goo

sgoo@bwh.harvard.edu

CONTACT