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

ClinicalTrials.gov ID: NCT07663422

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Official title

GU-228: Mycophenolate Mofetil in Combination With Prednisone as First-line Treatment of Immune Related Hepatitis Resulting From Checkpoint Inhibitor Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07663422
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Fox Chase Cancer Center; Other
Enrollment: 31 participants

Conditions and interventions

Conditions

Interventions

Mycophenolate Mofetil plus prednisone Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 23, 2026 (Actual)
Primary completion: Mar 31, 2028 (Estimated)
Completion: Sep 30, 2028 (Estimated)
Last update posted: Sep 17, 2026

2026 – 2028

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Fox Chase Cancer Center	Philadelphia	Pennsylvania	19111	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07663422, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 17, 2026 · Synced Nov 13, 2026