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.
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