Actively Recruiting
Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
Led by Shilpa Grover, MD, MPH · Updated on 2025-11-04
80
Participants Needed
2
Research Sites
76 weeks
Total Duration
On this page
Sponsors
S
Shilpa Grover, MD, MPH
Lead Sponsor
D
Dana-Farber/Brigham and Women's Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
CONDITIONS
Official Title
Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Treatment with an immune checkpoint inhibitor for cancer within the past 8 weeks
- Confirmed diagnosis of immune checkpoint inhibitor-related colitis by endoscopy or biopsy
- Grade 2-3 diarrhea according to Common Terminology Criteria for Adverse Events
- Willing and able to follow study protocol requirements
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior history of inflammatory colitis needing prednisone over 10 mg daily or immunosuppressive medication
- Use of immunosuppressive biologic medication within 4 weeks
- Current immune-related adverse event requiring systemic steroids or immunosuppression within 2 weeks
- Colonic perforation or abscess
- Partial or complete bowel obstruction within last 3 months or signs of obstruction
- Active Clostridium difficile or other colonic infection
- Active hepatitis B or C infection
- Untreated tuberculosis or positive tuberculosis test without prophylaxis
- Active or prior infection with nontuberculous mycobacteria
- Unable or unwilling to undergo colonoscopy or flexible sigmoidoscopy
- Inpatient status at time of treatment (only outpatients allowed)
- History of total proctocolectomy
- Pregnancy, breastfeeding, or planning pregnancy within 6 months
- Unable to give informed consent
- Recent SARS-CoV-2 infection within 10 days (mild) or 20 days (severe) before first Vedolizumab dose
- Unable to follow protocol requirements
- Any condition deemed unsafe by investigators
- Allergy to sulfamethoxazole-trimethoprim
- Weight over 120 kg
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Shilpa Grover, MD, MPH
CONTACT
S
Seonyoung Goo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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