GLUCOCORTICOID HIGH-DOSE VS. GLUCOCORTICOID REPLACEMENT THERAPY IN IMMUNE CHECKPOINT INHIBITOR ASSOCIATED INFLAMMATION OF THE PITUITARY GLAND: AN OPEN, RANDOMIZED PILOT STUDY
- Conditions
- 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).Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2017-001915-35-AT
- Lead Sponsor
- Medical University of Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-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
-Patients currently already on glucocorticoid therapy will be excluded
-Patients with pre-existing pituitary or adrenal diseases will be excluded
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method