Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

This study is an open-label phase 2 study to evaluate the safety and efficacy of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer.

Inclusion Criteria:Histologically confirmed as anaplastic thyroid cancerUnresectable anaplastic thyroid cancerHave measurable lesions defined by the RECIST version 1.1Have adequate organ functionCardiac function test within 28 days before enrollment 12-lead electrocardiogram no clinically significant abnormality as shown below: heart disease, severe arrhythmia, etc.Patients who are 20 years or olderEastern Cooperative Oncology Group (ECOG) performance status 0-1Ability to swallow oral medicationsWomen of childbearing potentialLife expectancy of more than 90 daysHave signed written informed consent to participate in this studyExclusion Criteria:Active brain metastases or leptomeningeal metastasesDiverticulitis or Symptomatic ulcerative diseaseTreatment required complication of systemic infectious diseaseMedical history of active, known, or suspected autoimmune diseaseComplication of pulmonary fibrosis or interstitial pneumonitisMedical history of clinically significant cardiovascular disease within 180 days of initial dose as New York Heart Association (NYHA) class above 2 leveled congestive heart failure, unstable angina, cardiac infarction or cardiac arrhythmia with paroxysmal or required treatmentRegardless of usage of antihypertensive drug, systolic blood pressure <=140 mm Hg and diastolic blood pressure <=90 mm HgHave active double cancerCurrently receiving other interventional clinical study treatment