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New pill combo shows promise for tough thyroid cancer

NCT ID NCT04940052

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 study tests whether two targeted cancer pills, dabrafenib and trametinib, can help people with advanced thyroid cancer that has a specific gene change (BRAF V600E) and no longer responds to radioactive iodine. About 153 adults who have already tried one or two other treatments are taking part. The main goal is to see if the drug combo slows cancer growth compared to a placebo.

What this could mean

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

Active substance
dabrafenib and trametinib (targeted cancer drugs taken as pills)
What this could lead to
If this works, it could offer a new treatment option for people with a specific type of advanced thyroid cancer that has stopped responding to standard therapies.
What could go wrong
This is a phase 3 trial, but results are not yet final. The drugs may not improve survival for all patients, and side effects like fever, rash, or heart problems are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

153 people

The number who actually took part.

Started

Nov 2021

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 99 years

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.

Key Inclusion Criteria: * Signed informed consent * Male or female ≥ 18 years of age at time of informed consent * Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated thyroid carcinoma * Radioactive-iodine refractory disease * BRAF V600E mutation-positive tumor sample as per central laboratory result * Has progressed on at least 1 but not more than 2 prior VEGFR targeted therapies * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * At least one measurable lesion as defined by RECIST v1.1. Key Exclusion Criteria: * Anaplastic or medullary carcinoma of the thyroid * Previous treatment with a BRAF inhibitor and/or a MEK inhibitor * Concomitant RET Fusion-Positive Thyroid Cancer * Treatment with any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization * Treatment with any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization * Treatment with radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization * A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

differentiated thyroid carcinoma

As listed by the trial registrant

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

Differentiated thyroid cancer (DTC)

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Northwestern University Med School

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1417DTB, Argentina

  • Novartis Investigative Site

    Rio de Janiero, Rio de Janeiro, 20231-050, Brazil

  • Novartis Investigative Site

    Blumenau, Santa Catarina, 89015-200, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01246-000, Brazil

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2, Canada

  • Novartis Investigative Site

    London, Ontario, N6A 5W9, Canada

  • Novartis Investigative Site

    Fuzhou, Fujian, 350014, China

  • Novartis Investigative Site

    Zhengzhou, Henan, 450008, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Changsha, Hunan, 410013, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210006, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009, China

  • Novartis Investigative Site

    Xuzhou, Jiangsu, 221003, China

  • Novartis Investigative Site

    Changchun, Jilin, 130033, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Tianjin, Tianjin Municipality, 300121, China

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Guangzhou, 510060, China

  • Novartis Investigative Site

    Shanghai, 200233, China

  • Novartis Investigative Site

    Tianjin, 300052, China

  • Novartis Investigative Site

    Tianjin, 300480, China

  • Novartis Investigative Site

    Hisar, Haryana, 125005, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Novartis Investigative Site

    Chennai, 600 020, India

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Seoul, 06351, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Tainan, 704302, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Edirne, Merkez, 22030, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    Adana, Yuregir, 01250, Turkey (Türkiye)

  • Novartis Investigative Site

    Hanoi, 100000, Vietnam

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