This phase II trial tests the safety and side effects of vedolizumab in combination with a short course of steroids, methylprednisolone and prednisone, and compares how well they work to using steroids alone in treating cancer patients with inflammation of the colon (colitis) caused by immune checkpoint inhibitors (ICI). Vedolizumab is a monoclonal antibody that is used to decrease inflammation in the colon. Anti-inflammatory drugs, such as methylprednisolone, lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Both vedolizumab and steroids are treatments for ICI-related colitis. However, currently, vedolizumab is used when patients have not improved with steroids. Giving vedolizumab in combination with a short course of steroids, methylprednisolone and prednisone, may be safe and tolerable and may be more effective than steroids alone in improving ICI-related colitis in cancer patients.
Additional locations may be listed on ClinicalTrials.gov for NCT06841705.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Shilpa Grover
Phone: 617-732-6389
PRIMARY OBJECTIVES:
I. To assess the efficacy of early vedolizumab treatment in combination with a short course of steroids (steroid burst) for the treatment of ICI colitis compared to standard course of steroids plus placebo (for vedolizumab).
II. Assess ICI colitis clinical outcomes in patients who received early vedolizumab treatment in combination with a short course of steroids (steroid burst) compared to standard course of steroids plus placebo (for vedolizumab).
III. Determine the impact of early vedolizumab treatment in combination with a short course of steroids (steroid burst) on safety and cancer outcomes and compare them to standard course of steroids plus placebo (for vedolizumab).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive vedolizumab intravenously (IV) over 30 minutes on weeks 0, 2, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive methylprednisolone IV once daily (QD) on days 1-3, prednisone orally (PO) QD on days 4-10 followed by tapering doses of steroid placebo PO QD from day 11 until complete. Patients on steroids longer than 21 days also receive antibiotic placebo PO daily on days 21 until prednisone dose < 10 mg daily. Additionally, patients undergo stool and blood sample collection throughout the study. Additionally, patients may undergo endoscopic examination at 8 weeks.
ARM B: Patients receive placebo IV over 30 minutes on weeks 0, 2, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive methylprednisolone IV QD on days 1-3, prednisone PO QD on days 4-10 followed by tapering doses of prednisone from day 11 until complete. Patients on steroids longer than 21 days also receive trimethoprim-sulfamethoxazole PO daily on days 21 until prednisone dose < 10 mg daily. Patients also undergo stool and blood sample collection throughout the study. Additionally, patients may undergo endoscopic examination at 8 weeks.
After completion of study treatment, patients are followed up at week 8 and then for up to 1 year post enrollment.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorShilpa Grover
