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

NCT04615988 | Recruiting FDA Drug

• 1 other identifier: GCO 19-1977
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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

Cancer; Thyroid; PD-1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  20 weeks

Secondary Outcomes (6)

• Number of participants with risk of developing autoimmune thyroid disease treated with two agents.

  20 weeks

• Correlation of development high grade immune toxicity from PD-1/PD-L1 inhibitor with baseline vitamin D status (deficient or not)

  20 weeks

• Baseline Assessment Questionnaire

  20 weeks

• On Treatment Symptom Questionnaire

  20 weeks

• Change in Thyroid antibody

  baseline and 20 weeks

Study Arms (1)

Participants being treated with immunotherapy

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

Other: blood draw and questionnaire completion; Other: questionnaire completion, blood collection

Interventions

blood draw and questionnaire completion OTHER

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

Participants being treated with immunotherapy

questionnaire completion, blood collection OTHER

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

Participants being treated with immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• History of clinical or subclinical hyperthyroidism or hypothyroidism
• Hemoglobin \< 9
• Inability to come for all study visits.
• Pregnant or lactating
• History of hypophysitis

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital /Tisch Cancer Cancer/Ruttenberg Treatment Center

New York, New York, 10029, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

MeSH Terms

Conditions

Thyroid Diseases; Neoplasms; Vitamin D Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philip Friedlander, MD PhD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Friedlander, MD PhD

CONTACT

2128248588; philip.friedlander@mssm.edu

Emily Gallagher, MD

CONTACT

2122413422; emilygallagher@mssm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: June 9, 2021
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)