SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial

NCT07421869 | Recruiting

• 1 other identifier: IRB-B-2401-879-001
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to find out whether hypothyroidism caused by immune checkpoint inhibitors (ICIs) can recover after stopping the ICIs. The study also aims to identify factors that can help predict which patients will be able to stop taking thyroid hormone replacement. The main questions the study will answer are:

• What percentage of patients recover normal thyroid function and can stop levothyroxine after stopping ICIs?
• What clinical or laboratory factors can predict successful withdrawal of levothyroxine? Participants will:
• Be adult cancer patients who developed hypothyroidism during ICI treatment and are currently taking levothyroxine
• Have already stopped ICI therapy
• Gradually reduce their levothyroxine dose every 3 months if their thyroid function remains normal
• Stop levothyroxine if thyroid function remains normal at low doses (≤0.025 mg)
• Be monitored with thyroid function tests and clinical symptoms at each visit

Conditions

Hypothyroidism

Keywords

Hypothyroidism; Immune checkpoint inhibitors; Thyroid hormones; Levothyroxine

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who maintain discontinuation of levothyroxine for at least 6 months

  The number and proportion of participants who are able to remain off levothyroxine for at least 6 consecutive months without requiring re-initiation of treatment due to abnormal thyroid function (serum TSH level ≥10 μIU/mL).

  Up to 6 months after levothyroxine discontinuation

Secondary Outcomes (3)

• Proportion of participants who can discontinue levothyroxine

  up to 3 years after study enrollment

• Proportion of participants who maintain discontinuation of levothyroxine for at least 12 months

  Up to 12 months after levothyroxine discontinuation

• Proportion of participants who maintain discontinuation of levothyroxine for at least 36 months

  Up to 36 months after levothyroxine discontinuation

Study Arms (1)

Levothyroxine tapering arm

EXPERIMENTAL

Participants will undergo a gradual dose reduction of levothyroxine according to a standardized tapering protocol. The levothyroxine dose will be reduced every 3 months based on thyroid function test results. If thyroid function remains stable, the dose will be decreased by 0.025 mg (±0.0125 mg). If thyroid function remains stable at a low dose (≤0.025 mg), levothyroxine will be discontinued.

Drug: Levothyroxine tapering

Interventions

Levothyroxine tapering DRUG

Participants will undergo a gradual dose reduction of levothyroxine according to a standardized tapering protocol. The levothyroxine dose will be reduced every 3 months based on thyroid function test results. If thyroid function remains stable, the dose will be decreased by 0.025 mg (±0.0125 mg). If thyroid function remains stable at a low dose (≤0.025 mg), levothyroxine will be discontinued.

Levothyroxine tapering arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older.
• Patients with a history of treatment with immune checkpoint inhibitors (ICIs).
• Developed hypothyroidism during ICI treatment and initiated levothyroxine after starting ICI therapy.
• Discontinued ICI therapy prior to study enrollment.

You may not qualify if:

• Use of levothyroxine or antithyroid medications within 3 months prior to initiating ICI therapy.
• History of thyroid surgery, radioactive iodine therapy, or neck radiation therapy.
• Current levothyroxine dose ≥0.1 mg at the time of enrollment.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Department of Internal Medicine, Seoul National University Bundang Hospital

Seongnam-si, South Korea

RECRUITING

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Central Study Contacts

Min Joo Kim, Professor

CONTACT

+82-31-787-7855; mjkim@snubh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a prospective, single-group, open-label study designed to evaluate the potential for recovery from immune checkpoint inhibitor (ICI)-induced hypothyroidism after discontinuation of ICI therapy. All participants will receive a standardized protocol for stepwise reduction of levothyroxine dosage based on thyroid function tests. No comparator group is included.

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 19, 2026
• Study Start: June 12, 2024
• Primary Completion (Estimated): March 4, 2029
• Study Completion (Estimated): March 4, 2029
• Last Updated: February 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)