Study of Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer

• Status: Not yet recruiting
• Trial end date: 2026-10-30
• Target enrollment: 0
• Participant gender: All

Summary

150 adults patients with locally advanced or metastatic BRAFV600E mutation-positive, differentiated thyroid carcinoma who are refractory to radioactive iodine and have progressed following prior VEGFR targeted therapy will enter in the trial. Patients will be randomized in a 2:1 ratio to either dabrafenib plus trametinib or placebo. Patients will be stratified by number of prior VEGFR targeted therapy (1versus2) and prior lenvatinib treatment (yes versus no)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Dabrafenib; Trametinib

Criteria

Inclusion Criteria:

• Signed informed consent must be obtained prior to performing any specific pre-screening and screening procedure

• Male or female >= 18 years of age at the time of informed consent

• Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated thyroid cancer

• Radio active iodine refractory disease

• BRAFV600E mutation positive tumor sample as per Novartis designated central laboratory result

• Has progressed on at least 1 but not more than 2 prior VEGFR targeted therapy

• Eastern Cooperative Oncology Group performance status >= 2

• At least one measurable lesion as defined by RECIST 1.1

Exclusion Criteria:

• Anaplastic or medullary carcinoma of the Tyroid

• Previous treatment with BRAF inhibitor and/or MEK inhibitor

• Concomitant RET Fusion Positive Thyroid cancer

• Receipt of any type of small molecule kinase inhibitor within 2 weeks before randomization

• Receipt of any type of cancer antibody or systemic chemotherapy within 4 weeks before randomization

• Receipt of 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 or central serous retinopathy