Early vedolizumab as first-line treatment for immune-related colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase II trial compares vedolizumab plus a short steroid regimen to the standard steroid course for adults with grade 2–3 immune checkpoint inhibitor–related colitis. Participants receive three vedolizumab or placebo infusions over six weeks, a short course of IV methylprednisolone and oral prednisone with either a prednisone taper or placebo taper, and sulfamethoxazole-trimethoprim or placebo as prophylaxis. Baseline and possible follow-up sigmoidoscopies/colonoscopies with biopsies, plus blood and stool samples, are collected for clinical and research purposes, and participants complete weekly follow-ups. The primary outcome is resolution of colitis at 8 weeks, with safety and steroid exposure as key secondary considerations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Shilpa Grover, MD, MPH — Brigham and Women's Hospital
• Study coordinator: Shilpa Grover, MD, MPH
• Email: sgrover@bwh.harvard.edu
• Phone: 6177326389

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.