Lenvatinib and Pembrolizumab Simultaneous Combination Study

Exclusion Criteria

• •1. Patients who received prior anticancer treatment within 14 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 28 days prior to the first dose of study drugs.
• •2. Patients who have undergone surgical treatment and radiotherapy with in 2 weeks before enrollment.
• •3. Patients with a history of prior treatment with Lenvatinib or any anti-programmed death 1, anti-programmed ligand death 1, or anti-programmed ligand death 2.
• •4. Patients with hypertension that is difficult to control (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents.
• •5. Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment.
• •6. Patients with symptomatic brain metastasis.
• •7. Patients with a history of New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months
• •8. Patients have an active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months
• •9. Patients have severe (hospitalization required) complications (intestinal palsy, intestinal obstruction, pulmonary fibrosis, diabetes difficult to control, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, mental disease, cerebrovascular disease etc).
• •10. Patients with a history of a gastrointestinal perforation and /or gastrointestinal fistula within 6 months before enrollment.
• •11. Patients with active hepatitis.
• •12. Patients with a history of human immunodeficiency virus (HIV).
• •13. Patients with active symptoms or signs of interstitial lung disease.
• •14. Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease
• •15. Patients who require systemic corticosteroids (excluding temporary usage for tests, prophylactic administration for allergic reactions, or to alleviate swelling associated with radiotherapy) or immunosuppressants, or who have received such a therapy \<14 days before enrollment.
• •16. Patients have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis
• •17. Patients who are administered live vaccines \<30 days before the initiation of treatment with the investigational drug.
• •18. Patients have serious non-healing wound, ulcer, or bone fracture.
• •19. Females who are pregnant or breastfeeding
• •20. Patients have no intention to comply with the protocol or cannot comply.
• •21. Patients were judged unsuitable as subject of this trial by investigator.