drugset / Trial / NCT07663422

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

NCT07663422

Phase 2 Not yet recruiting 31 enrolled Fox Chase Cancer Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-06-30
Primary completion
2028-03-31
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Mofetil Small molecule 1000 mg Oral
Subject Prednisone Other / unclassified

Indications