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

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

• Immune Checkpoint Inhibitor-Related Colitis

Interventions

DRUG

Vedolizumab 300 MG Injection [Entyvio]

This is a biologic medication to treat colitis

DRUG

Prednisone (and methylprednisolone)

This is a steroid

DRUG

Prednisone Taper

This is a tapering dose of prednisone

OTHER

Placebo Prednisone Capsules

Placebo for Prednisone

OTHER

Placebo Vedolizumab

Placebo for Vedolizumab

OTHER

Sulfamethoxazole-Trimethoprim

Antibiotic if on \>21 days of steroids

DRUG

Placebo for Sulfamethoxazole-Trimethoprim

Placebo for antibiotic (Sulfamethoxazole-Trimethoprim) Antibiotic. Only if on \>21 days of prednisone/placebo

Sponsors & Collaborators

• Dana-Farber/Brigham and Women's Cancer Center

  collaborator OTHER

• Takeda

  collaborator INDUSTRY

• Shilpa Grover, MD, MPH

  lead OTHER

Principal Investigators

• Shilpa Grover, MD, MPH · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-15

Primary Completion

2026-07-30

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations