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.
I. To assess the overall rate of response among study participants treated with the
combination of encorafenib and binimetinib, with or without nivolumab.
I. To assess the progression-free survival (PFS) among study participants treated with the
combination of encorafenib and binimetinib with or without nivolumab.
II. To assess the overall survival (OS) among study participants treated with the combination
of encorafenib and binimetinib with or without nivolumab.
III. To evaluate the duration of response (DOR). IV. To evaluate the safety and tolerability
of study participants treated with the combination of encorafenib and binimetinib with or
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive encorafenib orally (PO) once daily (QD) and binimetinib PO twice
daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression
or unacceptable toxicity.
ARM II: Patients receive encorafenib PO QD and binimetinib PO BID as in arm I. Patients also
receive nivolumab intravenously (IV) over 30 minutes on day 1. Cycles with nivolumab repeat
every 28 days for up to 2 years in the absence of disease progression or unacceptable
After completion of study treatment patients are followed up at 30 days and then every 6
months for up to 12 months.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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