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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: Recruiting Phase 2 study of Immune Checkpoint Inhibitor-Related Colitis, sponsored by Shilpa Grover, MD, MPH.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Defined as less than 10 mg of prednisone/day and grade 1 or lower diarrhea symptoms without the use of additional biologic rescue medication.
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 |
What NCT06841705 shows while recruiting
NCT06841705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06841705's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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