A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

• Biliary Tract Cancer with 1 prior line of therapy
• Adjuvant therapy only counts as prior line if recurrence within 6 months of completing tx
• Measurable Disease per RECIST 1.1
• Archival tissue or newly obtained tissue available
• ECOG PS 0-1
• BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
• No evidence of malabsorption syndrome
• No evidence of major blood vessel involvement
• No clinically significant hemoptysis or tumor bleeding
• No arterial thromboembolism within 12 months
• No significant CAD within 12 months
• No prior lenvatinib or checkpoint inhibitor therapy
• Prior bevacizumab is allowed
• No proteinuria defined as Uprotein >1g/24 hours
• LVEF must be 55% or greater
• No chronic systemic steroid or immunosuppressive therapy
• No diagnosis of immunodeficiency
• No active CNS metastases
• No tumor involving the brain stem
• No active autoimmune disease that has required treatment within last 2 years
• No known HIV/HBV/HCV

Primary- ORR, safety

Secondary- DCR, DoR, PFS, OS, PK