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New treatment option for Immune Checkpoint Inhibitor-Related Colitis
Official title Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
ClinicalTrials.gov ID: NCT06841705
What this study is testing
What is Vedolizumab 300 MG Injection [Entyvio]?
Vedolizumab 300 MG Injection [Entyvio] is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for immune checkpoint inhibitor-related colitis.
Also referred to as Entyvio.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to participate in the study, a patient must meet all the following
- 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.
You likely can't join 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...
- Active Clostridium difficile or other colonic infection.
See the full eligibility criteria
- In order to participate in the study, a patient must meet all the following
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.