Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors

ID#: NCT04615988

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: June 09, 2021

End Date: June 01, 2024

Contact Information:
Philip Friedlander, MD PhD
Emily Gallagher, MD

The purpose of this research study is to see if the amount of vitamin D in ones blood makes it more or less likely to develop thyroid gland toxicity when being treated with immunotherapy that blocks the activity of proteins called programed death-1(PD-1) or programmed death ligand-1 (PD-L1). Immunotherapy is treatment that makes changes to the immune system to try to fight cancer. Immunotherapy treatments that block the activity of important parts of the immune system called PD-1 and PD-L1 are used to standardly treat many different types of cancer and can cause thyroid toxicity in certain people. In this study the treatment for your cancer is not research treatment but standard of care determined by your oncologist. Blood will be drawn before starting treatment to determine the amount of Vitamin D and also to assess thyroid function. Also questionnaires will be completed before starting treatment and while on treatment to assess symptoms you are experiencing.


Inclusion Criteria:

- Malignancy which the treating oncologist plans for next treatment to inhibit PD-1or PD-L1 with the immune inhibitor being the only immunotherapy. Twenty-five subjects in a separate cohort will need for eligibility to be planned for treatment with anti-PD1/PD-L1 plus antri-CTLA-4 therapy.

- Willingness to complete symptom questionnaires

- Willingness to allow blood draws

- Ability to provide informed consent

- Age > 18 years old

Exclusion Criteria:

- History of clinical or subclinical hyperthyroidism or hypothyroidism

- Hemoglobin < 9

- Inability to come for all study visits.

- Actively on vitamin D supplementation due to vitamin D deficiency (As part of a multivitamin is not exclusionary)

- Pregnant or lactating

- History of hypophysitis