Fox Chase Cancer Center
This phase II study evaluates whether early treatment with mycophenolate mofetil (MMF) plus prednisone improves liver inflammation caused by immune checkpoint inhibitors. The study includes patients who develop moderate to severe immune-related hepatitis after receiving PD-(L)1 or CTLA-4-based cancer therapy. The main goal is to determine how many patients experience improvement in liver function within 30 days while successfully tapering steroids. Safety and treatment-related side effects will also be monitored.
This is a phase II, interventional clinical trial evaluating the efficacy and safety of combination immunosuppression with mycophenolate mofetil (MMF) plus prednisone for the treatment of grade 2-3 immune-related adverse event (irAE) hepatitis associated with immune checkpoint inhibitor therapy (PD-(L)1 and/or Cytotoxic T-lymphocyte associated protein 4 (CTLA-4) inhibitors). Eligible patients are those with laboratory-defined grade 2-3 hepatitis and a clinical diagnosis consistent with irAE hepatitis. When feasible, liver biopsy is obtained within 120 hours of diagnosis to confirm the diagnos…
Inclusion Criteria: * Patients must be ≥ 18 years at the time of irAE diagnosis and must have been diagnosed with a solid tumor or hematologic malignancy being treated with non-curative intent. * Patients must be diagnosed or presumed to have by a treating Medical Oncology or Hematology-Oncology clinician with immune-related hepatitis, G2-G3 (as defined in section 11.0), with plan for at least temporary interruption of IO therapy and initiation of corticosteroid treatment. * Patients must have been previously treated for any malignancy with at least one dose of an IO agent targeting the Progr…
MMF dosing is 1000 mg orally twice daily, and dosing for individual patients will be managed based on toxicity monitoring rules. The addition of alternative agents for treatment of irAEs will be at the treating Oncologist/Hematologist's discretion. Patients for whom prednisone is held may resume those agents at treating Oncologist/Hematologist's discretion, while rules for MMF re-challenge are stipulated. At the end of the 30-day primary study period, patients may continue one or both agents as deemed appropriate by the treating physician.
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