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
NCT ID: NCT04940052
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
153 participants
INTERVENTIONAL
2021-11-15
2027-06-04
Brief Summary
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Detailed Description
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Patients randomized in the placebo arm for whom disease progression as per RECIST 1.1 is confirmed by Blinded Independent Review Committee (BIRC) and who meet the eligibility criteria outlined in the study protocol will be given the option to crossover to the open-label dabrafenib plus trametinib treatment.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Dabrafenib plus Trametinib
Eligible participants will receive Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor.
Dabrafenib
Dabrafenib 150 mg capsule administered orally twice a day (BID)
Trametinib
Trametinib 2 mg tablet administered once a day (QD)
Dabrafenib Placebo plus Trametinib Placebo
Eligible participants will receive matching placebo for Dabrafenib 150 mg twice a day (BID) and matching placebo for Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor.
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Northwestern University Med School
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Rio de Janiero, Rio de Janeiro, Brazil
Novartis Investigative Site
Blumenau, Santa Catarina, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Fuzhou, Fujian, China
Novartis Investigative Site
Zhengzhou, Henan, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Xuzhou, Jiangsu, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, China
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, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Chennai, , India
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia
Novartis Investigative Site
Kuching, Sarawak, Malaysia
Novartis Investigative Site
Kuala Lumpur, , Malaysia
Novartis Investigative Site
Seoul, Korea, 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, Turkey (Türkiye)
Novartis Investigative Site
Edirne, Merkez, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
Novartis Investigative Site
Adana, Yuregir, Turkey (Türkiye)
Novartis Investigative Site
Hanoi, , Vietnam
Countries
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Other Identifiers
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CDRB436J12301
Identifier Type: -
Identifier Source: org_study_id
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