Immune regulatory antibodies (e.g. ipilimumab, pembrolizumab and nivolumab) inhibiting immunological checkpoints are increasingly used to treat various oncological entities. Potential side effects of are immune-related adverse events such as hypophysitis, affecting up to 10–15% of patients receiving ipilimumab. Hypophysitis manifests mostly in the form of multiple anterior pituitary hormone deficiencies (mostly central hypothyroidism and central adrenal insufficiency).
Conditions
Interventions
Trade Name: Hydrocortone
Product Name: Hydrocortisone
Product Code: n.a.
Pharmaceutical Form: Tablet
INN or Proposed INN: HYD
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients treated with either Anti-CTLA4-antibodies alone or who are treated with a combination of anti-CTLA4 and anti-PD1 antibodies either at the Department of Dermatology or the Division of Oncology, Department of Internal Medicine - Patients = 18 years of age can be included in the study - Diagnosis of IH based on clinical, hormonal and/or radiologic findings Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients currently already on glucocorticoid therapy will be excluded - Patients with pre-existing pituitary or adrenal diseases will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aims of this single-centre, open, randomized study are to compare for the first time high-dose glucocorticoid treatment with glucocorticoid replacement therapy in immune-checkpoint-inhibitor associated hypophysitis. The primary outcome is the frequency of total (recovery of all hormonal axes) and partial immune-checkpoint-inhibitor associated hypophysitis resolution (recovery of at least one, but not all hormonal axes). The main hypothesis is that there are no significant differences in the frequency of resolution.;Secondary Objective: Secondary outcomes include adverse effects of high-dose glucocorticoid therapy.;Primary end point(s): The primary endpoint is the frequency of total (recovery of all hormonal axes) and partial immune-checkpoint-inhibitor associated hypophysitis resolution (recovery of at least one, but not all hormonal axes). ;Timepoint(s) of evaluation of this end point: After 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes include adverse effects of high-dose glucocorticoid therapy.;Timepoint(s) of evaluation of this end point: After 8 weeks. | — |
Countries
Austria
Contacts
Public ContactMedical University of Graz
Medical University of Graz
Outcome results
None listed