Infliximab for Treatment of Ipilimumab Colitis

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This research study is evaluating the effectiveness and safety of infliximab therapy compared with steroids in the treatment of ipilimumab-induced colitis in patients with III/IV melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Infliximab; Ipilimumab; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

• Age ≥ 18

• Stage III/IV melanoma

• Treatment with ipilimumab or ipilimumab in combination with PD-1or PD-L1 blockade within the past 8 weeks; investigational combinations will be permitted provided that they include ipilimumab and a drug targeting PD-1 and/or PD-L1

• Meets eligibility requires for treatment with ipilimumab

• Patients with brain metastases and who have received radiation are eligible

• Prior treatment with targeted or alternative immunotherapy is allowed, provided that these medications were discontinued prior to initiation of the current ipilimumab containing treatment regimen

• Grade 2-4 diarrhea by Common Terminology Criteria for Adverse Events (CTCAE) onset after treatment

• Prior to randomization, endoscopically determined colitis, according to Mayo Scoring system, score of 1-3

• Patients will be permitted to have received up to 3 doses of systemic corticosteroids within 72 hours (up to a maximum dose of 2 mg/kg) prior to endoscopy and randomization

• Hepatitis B surface antigen, surface antibody, and core antibody must be sent but will not need to be resulted prior to enrollment

Exclusion Criteria:

• Prior history of inflammatory colitis related to immune checkpoint inhibitors requiring treatment with > 10 mg/day of prednisone or equivalent, or any other immunosuppressive medication

• Concurrent immune-related Adverse Event (irAE) requiring treatment with systemic corticosteroids (dose equivalent of prednisone 10 mg/day or higher) or another systemic immune suppressing medication within the past 10 days

• Current use of any immune suppressing biologic medication, or use within the last 4 weeks; immune stimulating medications such as checkpoint blockade are explicitly permitted

• Current use of combination treatment with an investigation immunotherapy targeting a pathway other than PD-1 or PD-L1, concurrent chemotherapy, or targeted therapy

• Previous adverse reaction to infliximab or corticosteroids

• Colonic perforation or abscess

• History of Hepatitis B or C with a positive viral load, untreated mycobacterium tuberculosis, or active herpes zoster infection; current negative testing results will not be required to be sent prior to study enrollment

• Positive testing for C Difficile or another colonic infection

• Current bacterial infection requiring antibiotic treatment, or systemic fungal infection

• Prior history of inflammatory bowel disease, microscopic colitis or segmental colitis associated with diverticulosis