Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

Inclusion Criteria:

1. Histologically confirmed as anaplastic thyroid cancer

2. Unresectable anaplastic thyroid cancer

3. Have measurable lesions defined by the RECIST version 1.1

4. Have adequate organ function

5. Cardiac function test within 28 days before enrollment 12-lead electrocardiogram noclinically significant abnormality as shown below: heart disease, severe arrhythmia,etc.

6. Patients who are 20 years or older

7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

8. Ability to swallow oral medications

9. Women of childbearing potential

10. Life expectancy of more than 90 days

11. Have signed written informed consent to participate in this study

Exclusion Criteria:

1. Active brain metastases or leptomeningeal metastases

2. Diverticulitis or Symptomatic ulcerative disease

3. Treatment required complication of systemic infectious disease

4. Medical history of active, known, or suspected autoimmune disease

5. Complication of pulmonary fibrosis or interstitial pneumonitis

6. Medical history of clinically significant cardiovascular disease within 180 days ofinitial dose as New York Heart Association (NYHA) class above 2 leveled congestiveheart failure, unstable angina, cardiac infarction or cardiac arrhythmia withparoxysmal or required treatment

7. Regardless of usage of antihypertensive drug, systolic blood pressure <=140 mm Hgand diastolic blood pressure <=90 mm Hg

8. Have active double cancer

9. Currently receiving other interventional clinical study treatment