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

Conditions

• Immune-mediated Hepatitis
• Immune-related Adverse Event

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mycophenolate Mofetil plus prednisone — DRUG
  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.

Study Details

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.

Key Dates

First listed

Jun 23, 2026

Start date

Jul 23, 2026

Status verified

Sep 2026

Primary completion

Mar 31, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

31 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Mycophenolate mofetil (MMF) and prednisone
  Patients who present with G2-3 irAE hepatitis by lab value and confirmed diagnosis by liver biopsy will be treated with combination therapy of MMF plus prednisone for 30 days

Primary Outcome Measure

Response rate of immunotherapy (IO)-related hepatitis to MMF and prednisone [ Time Frame: 30 days ]

Central Contacts

• Ryan Romasko
  2678388380
  [email protected]

Locations (1)

Find similar trials in Philadelphia, PA

Related Studies

• Pharmacokinetic Study of Therapeutic Plasma Exchange
  Not Yet Recruiting · University of Chicago · Chicago, Illinois