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Immunotherapy side effect may be reversible: thyroid drug taper trial launches

NCT ID NCT07421869

Disease control Sponsor: Seoul National University Bundang Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at whether hypothyroidism caused by immune checkpoint inhibitors (a type of cancer immunotherapy) can go away after stopping the immunotherapy. 107 adult cancer patients who developed hypothyroidism during treatment and are now off immunotherapy will gradually reduce their thyroid medication (levothyroxine) every 3 months. The goal is to see how many can stop the medication completely and for how long.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levothyroxine tapering
What this could lead to
If successful, this could show that some patients can safely stop thyroid medication after finishing immunotherapy, reducing lifelong drug burden.
What could go wrong
This is a small, early-phase study without a control group. Many patients may still need lifelong thyroid hormone, and the tapering process could cause temporary symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 107 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

hypothyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypothyroidism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Internal Medicine, Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, South Korea

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