Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioi… (NCT04061980) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer
United States24 participantsStarted 2020-10-30
Plain-language summary
This phase II trial studies how well encorafenib and binimetinib given with or without nivolumab works in treating patients with BRAF V600 mutation positive thyroid cancer that has spread to other places in the body (metastatic) and does not respond to radioiodine treatment (refractory). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The trial aims to find out if the combination of encorafenib and binimetinib, with and without study nivolumab, is a safe and effective way to treat metastatic radioiodine refractory thyroid cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent document
* Histologically (or cytologically) confirmed diagnosis of metastatic, radioiodine (RAI) refractory, BRAFV600E/M mutant differentiated thyroid cancer (DTC)
* Note: RAI refractoriness is defined as:
* The absence of uptake of RAI on either a low-dose diagnostic whole body scan, or a post-treatment RAI scan in measurable lesions
* Radiographic progression of disease within 12 months of the last course of RAI treatment, or
* Having a cumulative lifetime administered dose of \> 600 mCi of RAI
* Measurable disease meeting the following criteria and confirmed by radiography review:
* At least 1 lesion of \>= 1.0 cm in the longest diameter for a non-lymph node or \> 1.5 cm in the short-axis diameter for a lymph node metastasis that is serially measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using computed tomography/magnetic resonance imaging (CT/MRI). If there is only 1 target lesion and it is a non-lymph node, it should have a longest diameter of \>= 1.5 cm
* Lesions that have had external beam radiotherapy or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
* Hemoglobin (Hgb) \>= 9 g/dL
* Platelets …
What they're measuring
1
Overall response rate (ORR)
Timeframe: From the start of randomization up to 6 months from first dose of study drugs