About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Eligible subjects are adults age 18 or older with advanced cancer and are planned to receive standard of care treatment with a PD-1/L-1 inhibitor or with standard of care anti-CTLA-4 plus antiPD-1/L1 inhibitors.
Trial design
Cohort
Prospective
Treatments tested in this trial
blood draw and questionnaire completion
Other interventionquestionaires provided to subjects during visits while on study and baseline one tube of blood drawn
questionnaire completion, blood collection
Other interventionquestionnaire provided to subject during study visits. One tube blood collected for research purposes at baseline
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with risk of developing autoimmune thyroid disease treated with single agent.
Number of participants with risk of developing autoimmune thyroid disease in cancer treated with single agent anti-PD-1/PD-L1 therapy with baseline pre-treatment vitamin D deficiency compared with those with normal vitamin D levels
Secondary outcomes
Number of participants with risk of developing autoimmune thyroid disease treated with two agents.
Number of participants with risk of developing autoimmune thyroid disease in cancer patients treated with anti-CTLA-4 + anti-PD-1/PD-L1 therapy in patients with vitamin D deficiency, compared with those with normal vitamin D levels.
Correlation of development high grade immune toxicity from PD-1/PD-L1 inhibitor with baseline vitamin D status (deficient or not)
The risk of developing a high grade (\> gd 3) immune mediated toxicity in the 20 weeks. following initiation of treatment with a PD-1/PD-L1 inhibitor in cancer patients with baseline vitamin D deficiency will be compared to the risk in those with baseline normal vitamin D levels. Correlate baseline vitamin D status with development of thyroid toxicity.
Baseline Assessment Questionnaire
Participants using the Baseline Assessment Questionnaire rate symptoms on scale of 1-10 with higher number reflecting more severe symptom.
On Treatment Symptom Questionnaire
Symptom questionnaire using the On Treatment Symptom Questionnaire - full score 1-10 with increasing number reflecting more severe symptom.
Sponsors and contacts
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