Recruiting

Immunotherapy with Vitamin D

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT04615988

Conditions

Thyroid

PD-1

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

blood draw and questionnaire completion

questionnaire completion, blood collection

Study Details

Brief summary:

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.

Conditions

Thyroid

PD-1

Cancer

Study ID

NCT04615988

Start date

Jun 9, 2021

Status verified date

Mar, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

17 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants being treated with immunotherapy

Participants who are to receive standard of care immunotherapy targeting PD-1 or PDL1 as treatment for malignancy

Interventions

blood draw and questionnaire completion

questionaires provided to subjects during visits while on study and baseline one tube of blood drawn

questionnaire completion, blood collection

questionnaire provided to subject during study visits. One tube blood collected for research purposes at baseline

Primary outcome measure

  • Number of participants with risk of developing autoimmune thyroid disease treated with single agent. [ Time Frame: 20 weeks ]

Central Contacts and Locations

Central contacts

Philip Friedlander, MD PhD

2128248588philip.friedlander@mssm.edu

Emily Gallagher, MD

2122413422emilygallagher@mssm.edu

Locations

Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center

Recruiting

New York, New York, United States, 10029

Contacts

Philip Friedlander, MD PhD

2128248588philip.friedlander@mssm.edu

Principal Investigator:

Philip Friedlander, MD PhD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • vitamin D deficiency
  • immunotherapy with inhibitor of PD-1/L1
  • immune mediated thyroid toxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-03-27.