Poorly Differentiated Thyroid Gland Carcinoma Clinical Trial
Official title:
Lenvatinib in Combination With Pembrolizumab for Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer
This phase II trial studies how well lenvatinib and pembrolizumab work in treating patients with anaplastic thyroid cancer that is stage IVB and has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable), or stage IVC that has spread to other places in the body (metastatic). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Given lenvatinib and pembrolizumab may work better than giving either one alone in treating stage IVB or C anaplastic thyroid cancer.
PRIMARY OBJECTIVE: I. Demonstrate the efficacy (overall survival [OS]) of lenvatinib plus pembrolizumab in treatment naive patients. SECONDARY OBJECTIVES: I. Determine the response rate and progression-free survival (PFS) in patients treated with lenvatinib plus pembrolizumab. II. Establish safety for concurrent administration of lenvatinib plus pembrolizumab. EXPLORATORY OBJECTIVE: I. Translational endpoints: cell-free deoxyribonucleic acid (DNA) changes and immune biomarkers will be studied. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenvatinib orally (PO) daily on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. ;
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