Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)

Inclusion Criteria

• •1. Voluntary agreement to provide written informed consent of this study.
• •2. Willing and able to comply with all aspects of the protocol after being fully informed of the content.
• •3. Males or females aged greater than or equal to 20 years at the time of informed consent.
• •4. Histological or cytological confirmation of RCC.
• •5. Participants must have confirmed diagnosis of unresectable advanced and/or metastatic RCC.
• •6. Disease progression following vascular endothelial growth factor (VEGF) targeted therapy.
• •7. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 to 1.
• •8. Adequately controlled blood pressure with or without the use of antihypertensive agents.
• •9. Participants with adequate function of major organs.
• •10. Adequate blood coagulation function, defined as international normalized ratio (INR) less than or equal to 1.5.
• •11. Survival expectation of 3 months or longer after study enrollment.
• •12. Participants with adequate washout period from the end of prior treatment to the start of study drug administration.
• •13. Females of childbearing potential must not have had unprotected sexual intercourse within 28 days before participant registration and must agree to use a highly effective method of contraception throughout the entire study period and for 30 days after final administration of investigational drug. If currently abstinent, the participant must agree to use a double-barrier method as described above if she becomes sexually active during this study period or for 30 days after investigational drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before administration and must continue to use the same contraceptive during this study and for 30 days after investigational drug discontinuation.
• •14. Male participants and their female partners must meet the criteria above.