This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation.
Name: Trametinib
Name: Dabrafenib
Name: 131I
Name: rhTSH
Description: Propotion of patients with a best overall response of Complete Response (CR) or a Partial Response (PR)
Measure: Objective Response Rate (ORR) Time: Evaluated 6 months after the first dose of trametinib or trametinib and dabrafenib followed by RAI treatment in each armsAllocation: Non-Randomized
Parallel Assignment
There is one SNP
Inclusion Criteria: - Patients with thyroid carcinoma of follicular origin (papillary, follicular or poorly differentiated and their respective variants) - Known positive RAS (NRAS or KRAS or HRAS) or BRAFV600E or K601E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples sent for central testing or on a biopsy sample sent for central testing). --- K601E ---
- Active infection requiring systemic therapy - Active malignancy (except for DTC, or definitively treated melanoma insitu, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 months - Any history of or concomitant medical condition that, in the opinion of the investigator, would compromise subject's ability to safely complete the protocol - Females who are pregnant or breastfeeding - Patients with an injection of radio-contrast agent within 8 weeks prior enrolment - Previous history of retinal vein occlusion - Previous history of central serious retinopathy - Known hypersensitivity to the study drugs or to any of the excipients Inclusion Criteria: - Patients with thyroid carcinoma of follicular origin (papillary, follicular or poorly differentiated and their respective variants) - Known positive RAS (NRAS or KRAS or HRAS) or BRAFV600E or K601E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples sent for central testing or on a biopsy sample sent for central testing). --- K601E ---