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Clinical Trials in South Korea / NCT04940052
Active, not recruiting Phase 3

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer

NCT04940052 · tracked via the Priya Life Science South Korea tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2021-11-15
Last updated
2026-09-21

Condition(s) studied

Differentiated Thyroid Cancer (DTC)

Investigational drug(s) / intervention(s)

Dabrafenib →Trametinib →Trametinib PlaceboDabrafenib placebo

Dabrafenib: Dabrafenib 150 mg capsule administered orally twice a day (BID)

Trametinib: Trametinib 2 mg tablet administered once a day (QD)

Trametinib Placebo: matching placebo tablet for Trametinib 2 mg will be administered orally once a day (QD)

Dabrafenib placebo: matching placebo capsule for Dabrafenib 150 mg will be administered orally twice a day (BID)

Study summary

The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the BRAFV600E mutation, who are refractory to radioactive iodine (RAI) therapy and have experienced disease progression following one or two prior VEGFR-targeted treatments.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Progression Free Survival (PFS) — From randomization to first documented progression or deaths, whichever comes first, assessed up to approximately 3 years
    Progression Free Survival (PFS) was defined as the time from the date of randomization to the date of the first documented progression according to RECIST 1.1 based on Blinded Independent Review Committee (BIRC) assessment, or death due to any cause. The primary analysis was conducted after all patients had either completed a minimum of 16 weeks of treatment or discontinued earlier, and following the occurrence of approximately 95 PFS events (Data cut-off date for the primary analysis was 22 January 2025).

Trial sites (41)

FacilityCityRegionStatus
Northwestern University Med School Chicago Illinois
Massachusetts General Hospital Boston Massachusetts
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site Rio de Janiero Rio de Janeiro
Novartis Investigative Site Blumenau Santa Catarina
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site Edmonton Alberta
Novartis Investigative Site London Ontario
Novartis Investigative Site Fuzhou Fujian
Novartis Investigative Site Zhengzhou Henan
Novartis Investigative Site Wuhan Hubei
Novartis Investigative Site Changsha Hunan
Novartis Investigative Site Nanjing Jiangsu
Novartis Investigative Site Nanjing Jiangsu
Novartis Investigative Site Xuzhou Jiangsu
Novartis Investigative Site Changchun Jilin
Novartis Investigative Site Chengdu Sichuan
Novartis Investigative Site Tianjin Tianjin Municipality
Novartis Investigative Site Beijing China
Novartis Investigative Site Beijing China
Novartis Investigative Site Guangzhou China
Novartis Investigative Site Shanghai China
Novartis Investigative Site Tianjin China
Novartis Investigative Site Tianjin China
Novartis Investigative Site Hisar Haryana
Novartis Investigative Site New Delhi National Capital Territory of Delhi
Novartis Investigative Site Chennai India
Novartis Investigative Site George Town Pulau Pinang
Novartis Investigative Site Kuching Sarawak
Novartis Investigative Site Kuala Lumpur Malaysia
Novartis Investigative Site Seoul South Korea
Novartis Investigative Site Seoul South Korea
Novartis Investigative Site Seoul South Korea
Novartis Investigative Site Seoul South Korea
Novartis Investigative Site Tainan Taiwan
Novartis Investigative Site Taipei Taiwan
Novartis Investigative Site Istanbul Fatih
Novartis Investigative Site Edirne Merkez
Novartis Investigative Site Ankara Yenimahalle
Novartis Investigative Site Adana Yuregir

+ 1 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in South Korea

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A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea Recruiting
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. Active, not recruiting
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04940052 on ClinicalTrials.gov ↗ ← All trials in South Korea