NCT06841705 · Shilpa Grover, MD, MPH
Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
(EVITA)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 4, 2025 · Source of record for eligibility and locations