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

NCT06841705 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24-080
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

Immunotherapy Colitis; Immune Checkpoint Inhibitor Colitis; ICI Colitis; Colitis

Outcome Measures

Primary Outcomes (1)

• Steroid-free remission rate

  Defined as less than 10 mg of prednisone/day and grade 1 or lower diarrhea symptoms without the use of additional biologic rescue medication.

  8 weeks

Secondary Outcomes (15)

• Steroid-free remission rate

  5 weeks

• Change in calprotectin

  0, 2, 5 and 8 weeks

• Cumulative steroid exposure

  5 weeks and 8 weeks

• Time to steroid-free colitis remission

  Up to 12 months

• Rate of secondary immunosuppression for management of ICI colitis

  5 weeks and 8 weeks

Other Outcomes (1)

• Time to resumption of cancer treatment

  12 months

Study Arms (2)

Vedolizumab and Short Course of Steroids

EXPERIMENTAL

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).

Drug: Vedolizumab 300 MG Injection [Entyvio]; Drug: Prednisone (and methylprednisolone); Other: Placebo Prednisone Capsules; Drug: Placebo for Sulfamethoxazole-Trimethoprim

Standard Course of Steroids

ACTIVE COMPARATOR

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.

Drug: Prednisone (and methylprednisolone); Drug: Prednisone Taper; Other: Placebo Vedolizumab; Other: Sulfamethoxazole-Trimethoprim

Interventions

Vedolizumab 300 MG Injection [Entyvio] DRUG

This is a biologic medication to treat colitis

Also known as: Entyvio

Vedolizumab and Short Course of Steroids

Prednisone (and methylprednisolone) DRUG

This is a steroid

Standard Course of Steroids; Vedolizumab and Short Course of Steroids

Prednisone Taper DRUG

This is a tapering dose of prednisone

Standard Course of Steroids

Placebo Prednisone Capsules OTHER

Placebo for Prednisone

Vedolizumab and Short Course of Steroids

Placebo Vedolizumab OTHER

Placebo for Vedolizumab

Standard Course of Steroids

Sulfamethoxazole-Trimethoprim OTHER

Antibiotic if on \>21 days of steroids

Standard Course of Steroids

Placebo for Sulfamethoxazole-Trimethoprim DRUG

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

Vedolizumab and Short Course of Steroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shilpa Grover, MD, MPH: lead
• Dana-Farber/Brigham and Women's Cancer Center: collaborator
• Takeda: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Colitis

Interventions

vedolizumab; Injections; Prednisone; Methylprednisolone; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prednisolone; Pregnadienetriols; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Shilpa Grover, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shilpa Grover, MD, MPH

CONTACT

6177326389; sgrover@bwh.harvard.edu

Seonyoung Goo

CONTACT

sgoo@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Onco-Gastroenterology, Division of Gastroenterology

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 24, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication. Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• Access Criteria: De-identified participant data from the final research dataset used in the published manuscript may be shared under the terms of a Data Use Agreement. Requests may be directed to sgrover@bwh.harvard.edu The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Locations

US (2)