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

NCT07663422 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-06-23

No results posted yet for this study

Summary

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.

Conditions

  • Immune-mediated Hepatitis
  • Immune-related Adverse Event

Interventions

DRUG

Mycophenolate Mofetil plus prednisone

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.

Sponsors & Collaborators

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Matthew Zibelman, MD · Fox Chase Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-03-31
Completion
2028-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663422 on ClinicalTrials.gov