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Recruiting NCT06841705

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

Phase II Interventional Immune Checkpoint Inhibitor-Related Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vedolizumab 300 MG Injection [Entyvio], Prednisone (and methylprednisolone), Prednisone Taper, Placebo Prednisone Capsules.
Who it may be relevant to
Registry conditions: Immune Checkpoint Inhibitor-Related Colitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

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

Primary outcome measures

  • Steroid-free remission rate [Time frame: 8 weeks]
Secondary outcome measures (12)
  • Steroid-free remission rate [Time frame: 5 weeks]
  • Change in calprotectin [Time frame: 0, 2, 5 and 8 weeks]
  • Cumulative steroid exposure [Time frame: 5 weeks and 8 weeks]
  • Time to steroid-free colitis remission [Time frame: Up to 12 months]
  • Rate of secondary immunosuppression for management of ICI colitis [Time frame: 5 weeks and 8 weeks]
  • Rate of symptomatic remission [Time frame: 5 weeks and 8 weeks]
  • Hospitalization rate [Time frame: 8 weeks]
  • Rates of colectomy [Time frame: 8 weeks]
  • Endoscopic resolution of colitis [Time frame: 8 weeks]
  • Best overall cancer response [Time frame: 8 weeks and 12 months]
  • Overall survival [Time frame: Time of death or 12 months]
  • Proportion of participants with an adverse event (AE) [Time frame: 5 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Brigham and Women's Hospital — Boston
  • Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT06841705 · 24-080

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗