Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

Prior treatment

• Regardless of usage of antihypertensive drug, systolic blood pressure \<=140 mm Hg and diastolic blood pressure \<=90 mm Hg
• Currently receiving other interventional clinical study treatment

Other illness

• Diverticulitis or Symptomatic ulcerative disease
• Treatment required complication of systemic infectious disease
• Medical history of active, known, or suspected autoimmune disease
• Complication of pulmonary fibrosis or interstitial pneumonitis
• Medical 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 treatment
• Have active double cancer

Other

• Active brain metastases or leptomeningeal metastases

• Histologically confirmed as anaplastic thyroid cancer
• Unresectable anaplastic thyroid cancer
• Have measurable lesions defined by the RECIST version 1.1
• Have adequate organ function
• Cardiac 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 older
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Ability to swallow oral medications
• Women of childbearing potential
• Life expectancy of more than 90 days
• Have signed written informed consent to participate in this study