Mycophenolate Mofetil w/ Prednisone for Immune Related Hepatitis From Checkpoint Inhibitor Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 Programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PDL-1) or CTLA-4 axis. IO use may have occurred at any time prior to diagnosis of irAE.
Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin must have been measured within screening window outlined in Section 8.0 (Study Calendar).
Disqualifiers
Patients previously treated for irAE hepatitis.
Patients diagnosed or presumed to have G4 immune-related hepatitis.
Patients receiving renal replacement therapy with hemodialysis or peritoneal dialysis at time of enrollment.
Patients with a documented history of Child-Turcotte-Pugh class B and C liver dysfunction.
Trial design
Design model
Single group
Treatments tested in this trial
Mycophenolate Mofetil plus prednisone
DrugMMF 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.
Treatment groups
31 Participants
are divided into 1 treatment groupGroup A: Mycophenolate mofetil (MMF) and prednisoneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Response rate of immunotherapy (IO)-related hepatitis to MMF and prednisone
The response rate of IO-related hepatitis to MMF and prednisone defined as achievement of corticosteroid (CS) dose of ≤ 20 mg prednisone with improvement to G1 or better as protocol defined at day 30 following treatment initiation
Time frame
30 daysSecondary outcomes
1
Frequency of bacterial, viral, or fungal infection requiring systemic treatment
The frequency of bacterial, viral, or fungal infection requiring systemic treatment within 90 days of initiation of MMF plus prednisone
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov