Health Trials

About this trial

This study evaluates the effectiveness of low-dose corticosteroids in managing grade 2-3 immune-related hepatitis in cancer patients treated with immune checkpoint inhibitors. It aims to determine whether of 0.5-1miligram per kilogram bodyweight prednisolone is sufficient to manage immune-related hepatitis without the need for dose escalation or additional immunosuppressive therapy.

Eligibility criteria

Qualifiers

Cancer patients aged 18 years or older

Treatment with a programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) antibody, or a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or a combination of a PD-1 and CTLA-4 antibody, or a PD-1 and lymphocyte-activation gene 3 (LAG-3) antibody

Occurrence of immune-related hepatitis grade 2 to 3 (as per judgment of the investigator)

Ability of the patient to comply with the study procedures (management of immune-related hepatitis)

Disqualifiers

Previous Immune-related hepatitis that required systemic therapy

Treatment for Immune-related hepatitis has already been initiated with high-dose corticosteroids (>0.5 mg/kg body weight)

Immune-related hepatitis with bilirubin > 1.5 ULN or clinical suspicion of cholangitis or elevated INR (beyond baseline)

Immune-related hepatitis with grade 4 at first presentation

Trial design

Treatments tested in this trial

  • Low-dose corticosteroids for immune-related hepatitis grade 3
  • Low-dose corticosteroids for immune-related hepatitis grade 2

Treatment groups

63 Participants
are divided into 2 treatment groups

Locations

2
Switzerland
University Hospital Basel4031, BaselCanton of Basel-City, Switzerland
United Kingdom
Royal Marsden HospitalSW3 6JJ, London United Kingdom

Sponsors and collaborators

University Hospital, Basel, Switzerland

Lead sponsor

Royal Marsden NHS Foundation Trust

Collaborator

Odense University Hospital

Collaborator

UMC Utrecht

Collaborator

Source ClinicalTrials.gov