Recruiting
Phase 2

Vedolizumab vs. Steroids

Sponsor:

Shilpa Grover, MD, MPH

Code:

NCT06841705

Conditions

Immune Checkpoint Inhibitor-Related Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vedolizumab 300 MG Injection [Entyvio]

Prednisone (and methylprednisolone)

Prednisone Taper

Placebo Prednisone Capsules

Placebo Vedolizumab

Study Details

Brief 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

Study ID

NCT06841705

Start date

Jul 15, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Criteria for Adverse Events.
  • Willing and able to comply with the requirements of the protocol.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Exclusion Criteria
  • Prior history of inflammatory colitis requiring treatment with greater than prednisone 10 mg daily or equivalent or any immunosuppressive medication.
  • Current or recent use of immunosuppressive biologic medication (for any reason including ICI colitis) within 4 weeks.
  • Concurrent immune-related adverse event requiring systemic steroids or systemic immunosuppression within 2 weeks.
  • Colonic perforation or abscess.
  • Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.
  • Active Clostridium difficile or other colonic infection.
  • Concurrent hepatitis B or C infection.
  • History of untreated tuberculosis and/or positive quantiferon/Tspot test without previous tuberculosis prophylaxis, or untreated active infection with mycobacterium tuberculosis.
  • Active or known prior infection with nontuberculous mycobacteria (NTM).
  • Unable or unwilling to undergo a colonoscopy/flexible sigmoidoscopy.
  • Inpatient status, though patients can be screened while inpatients, they must be outpatient for the planned treatment of ICI colitis.
  • History of total proctocolectomy.
  • Female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months.
  • Patients who are unable to give informed consent.
  • Previous SARS-CoV-2 infection within 10 days for mild infections or 20 days for severe/critical illness prior to first Vedolizumab dose.
  • Unable to adhere to protocol requirements.
  • Any condition that the physician investigators deem unsafe, including other conditions or medications that the investigator determines will put the subject at greater risk from vedolizumab plus brief course of steroids.
  • Allergy to sulfamethoxazole-trimethoprim.
  • Weight greater than 120 kg.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vedolizumab and Short Course of Steroids

Participants in this arm will receive Vedolizumab infusions (3 doses) and steroids for 10 days (intravenous Medrol daily for 3 days and Prednisone daily for 7 days). Participants may also receive daily placebo (for Prednisone and Sulfamethoxazole-Trimethoprim).

active comparator: Standard Course of Steroids

Participants in this arm will receive steroids for 10 days (intravenous Medrol daily for 3 days and Prednisone daily for 7 days), followed by a steroid (Prednisone) taper. Participants may also receive Sulfamethoxazole-Trimethoprim (an antibiotic). Participants will receive 3 placebo infusions.

Interventions

Vedolizumab 300 MG Injection [Entyvio]

This is a biologic medication to treat colitis

Prednisone (and methylprednisolone)

This is a steroid

Prednisone Taper

This is a tapering dose of prednisone

Placebo Prednisone Capsules

Placebo for Prednisone

Placebo Vedolizumab

Placebo for Vedolizumab

Sulfamethoxazole-Trimethoprim

Antibiotic if on >21 days of steroids

Placebo for Sulfamethoxazole-Trimethoprim

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

Primary outcome measure

  • Steroid-free remission rate [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Shilpa Grover, MD, MPH

6177326389sgrover@bwh.harvard.edu

Seonyoung Goo

sgoo@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Shilpa Grover, MD, MPH

617-632-6389sgrover@bwh.harvard.edu

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Elad Sharon

elad_sharon@dfci.harvard.edu

More Information

Sponsor

Shilpa Grover, MD, MPH

Last update posted

Nov 4, 2025

Last verified

Nov, 2025

Keywords

  • Immunotherapy Colitis
  • Immune Checkpoint Inhibitor Colitis
  • ICI Colitis
  • Colitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shilpa Grover, MD, MPH on 2025-11-04.