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New drug combo shows promise against deadly thyroid cancer

NCT ID NCT05696548

Disease control Sponsor: National Cancer Center Hospital East Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study is testing a combination of two drugs, nivolumab and lenvatinib, in 51 people with anaplastic thyroid cancer that cannot be removed by surgery. The goal is to see if the treatment is safe and can shrink tumors. Anaplastic thyroid cancer is rare and fast-growing, so finding effective treatments is urgent.

What this could mean

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

Active substance
nivolumab and lenvatinib
What this could lead to
If successful, this combination could offer a new treatment option for a rare and aggressive thyroid cancer that is currently hard to treat.
What could go wrong
This is a small, early-phase trial with only 51 participants. The treatment may cause significant side effects, and it is not yet known if it improves survival.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

51 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Dec 2026

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

20 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: 1. Histologically confirmed as anaplastic thyroid cancer 2. Unresectable anaplastic thyroid cancer 3. Have measurable lesions defined by the RECIST version 1.1 4. Have adequate organ function 5. Cardiac function test within 28 days before enrollment 12-lead electrocardiogram no clinically significant abnormality as shown below: heart disease, severe arrhythmia, etc. 6. Patients who are 20 years or older 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 8. Ability to swallow oral medications 9. Women of childbearing potential 10. Life expectancy of more than 90 days 11. Have signed written informed consent to participate in this study Exclusion Criteria: 1. Active brain metastases or leptomeningeal metastases 2. Diverticulitis or Symptomatic ulcerative disease 3. Treatment required complication of systemic infectious disease 4. Medical history of active, known, or suspected autoimmune disease 5. Complication of pulmonary fibrosis or interstitial pneumonitis 6. Medical history of clinically significant cardiovascular disease within 180 days of initial dose as New York Heart Association (NYHA) class above 2 leveled congestive heart failure, unstable angina, cardiac infarction or cardiac arrhythmia with paroxysmal or required treatment 7. Regardless of usage of antihypertensive drug, systolic blood pressure \<=140 mm Hg and diastolic blood pressure \<=90 mm Hg 8. Have active double cancer 9. Currently receiving other interventional clinical study treatment

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Conditions

The condition(s) this trial relates to.

thyroid gland undifferentiated (anaplastic) carcinoma

As listed by the trial registrant

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

Anaplastic thyroid cancer

Contacts and locations

Locations

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681, Japan

  • Hokkaido University Hospital

    Hokkaido, Hokkaido, 060-8648, Japan

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558, Japan

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017, Japan

  • National Cancer Center Hospital

    Tokyo, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • Nippon Medical School Hospital

    Tokyo, Tokyo, 113-8603, Japan

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.