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Mycophenolate Mofetil w/ Prednisone for Immune Related Hepatitis From Checkpoint Inhibitor Therapy

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 30, 2026 to Jul 23, 2026
    • Eligibility criteria expanded, about 31 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07663422
Lead Sponsor Fox Chase Cancer Center
Conditions
(from sponsor)		 Immune-mediated Hepatitis, Immune-related Adverse Event
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov