Early Concomitant Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
Shilpa Grover, MD, MPH
Summary
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
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 colono…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugVedolizumab 300 MG Injection [Entyvio]
This is a biologic medication to treat colitis
- DrugPrednisone (and methylprednisolone)
This is a steroid
- DrugPrednisone Taper
This is a tapering dose of prednisone
- OtherPlacebo Prednisone Capsules
Placebo for Prednisone
- OtherPlacebo Vedolizumab
Placebo for Vedolizumab
- OtherSulfamethoxazole-Trimethoprim
Antibiotic if on \>21 days of steroids
- Drug
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts