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