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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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This is a phase II, randomized trial to evaluate the efficacy and safety of the drugs Vedolizumab, methylprednisolone, and prednisone to manage the side of effect of colitis caused by immune checkpoint inhibitors (ICIs).

The names of the treatments involved in this study are:

* Vedolizumab
* Methylprednisolone
* Prednisone
* Sulfamethoxazole-Trimethoprim

The FDA has approved Vedolizumab, methylprednisolone, and prednisone to treat many conditions affecting the immune system, including colitis.

Participants who enroll in this study will undergo one or more flexible sigmoidoscopies or colonoscopies as part of their clinical care. The first of these procedures would occur at the time of study enrollment, and the second may occur after several weeks of treatment at the discretion of the study doctor. During these procedures, biopsies will be collected for clinical purposes as well as for research purposes. Blood and stool samples will also be collected for research. Any extra samples for research would only be collected only if it is safe for the participant.

Participants will complete weekly follow-ups either over the phone or in-person. During these visits, participants will be asked about any new symptoms or changes in their health, their medications, and their symptoms. Blood for research may be collected at four of these visits if it coincides with a scheduled clinical blood draw.

Participants are expected to be on study treatment for 8 weeks. The study team will review their medical records at 12 months for any changes in their health.

It is expected that approximately 80 people will participate in this research study.

Conditions

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Immune Checkpoint Inhibitor-Related Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Vedolizumab 300 MG Injection [Entyvio]

Intervention Type DRUG

This is a biologic medication to treat colitis

Prednisone (and methylprednisolone)

Intervention Type DRUG

This is a steroid

Placebo Prednisone Capsules

Intervention Type OTHER

Placebo for Prednisone

Placebo for Sulfamethoxazole-Trimethoprim

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Prednisone (and methylprednisolone)

Intervention Type DRUG

This is a steroid

Prednisone Taper

Intervention Type DRUG

This is a tapering dose of prednisone

Placebo Vedolizumab

Intervention Type OTHER

Placebo for Vedolizumab

Sulfamethoxazole-Trimethoprim

Intervention Type OTHER

Antibiotic if on \>21 days of steroids

Interventions

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Vedolizumab 300 MG Injection [Entyvio]

This is a biologic medication to treat colitis

Intervention Type DRUG

Prednisone (and methylprednisolone)

This is a steroid

Intervention Type DRUG

Prednisone Taper

This is a tapering dose of prednisone

Intervention Type DRUG

Placebo Prednisone Capsules

Placebo for Prednisone

Intervention Type OTHER

Placebo Vedolizumab

Placebo for Vedolizumab

Intervention Type OTHER

Sulfamethoxazole-Trimethoprim

Antibiotic if on \>21 days of steroids

Intervention Type OTHER

Placebo for Sulfamethoxazole-Trimethoprim

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

Intervention Type DRUG

Other Intervention Names

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Entyvio

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No