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NCT06841705 · ClinicalTrials.gov registry record · Phase 2
Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
A Phase 2 study of Immune Checkpoint Inhibitor-Related Colitis, sponsored by Shilpa Grover, MD, MPH.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT06841705 is a Phase 2 study of Immune Checkpoint Inhibitor-Related Colitis that is actively recruiting participants, run by Shilpa Grover, MD, MPH. The registered enrollment target is 80 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT06841705, a Phase 2 study of Immune Checkpoint Inhibitor-Related Colitis, is actively recruiting participants, sponsored by Shilpa Grover, MD, MPH.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Vedolizumab 300 MG Injection [Entyvio]
- DRUG Prednisone (and methylprednisolone)
- DRUG Prednisone Taper
- OTHER Placebo Prednisone Capsules
- OTHER Placebo Vedolizumab
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-07-15 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06841705
The ClinicalTrials.gov registry entry for NCT06841705 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shilpa Grover, MD, MPH, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Immune Checkpoint Inhibitor-Related Colitis appearing as the primary indexed condition, and to 5 interventions - of which Vedolizumab 300 MG Injection [Entyvio] is the first listed.
NCT06841705 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06841705 about?
NCT06841705 is a clinical study titled "Early Vedolizumab as First-Line for Immune-Related Colitis Therapy 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 p...
What is the current status of trial NCT06841705?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2025-07-15. Estimated completion is 2026-12-31.
What conditions does trial NCT06841705 study?
This clinical trial studies the following conditions: Immune Checkpoint Inhibitor-Related Colitis.
What interventions are being tested in trial NCT06841705?
The interventions under investigation include: Vedolizumab 300 MG Injection [Entyvio] (DRUG), Prednisone (and methylprednisolone) (DRUG), Prednisone Taper (DRUG), Placebo Prednisone Capsules (OTHER), Placebo Vedolizumab (OTHER).
Who is sponsoring clinical trial NCT06841705?
This trial is sponsored by Shilpa Grover, MD, MPH, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06841705 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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