BILIARY TRACT: METASTATIC: 2nd Line: LEAP-005-Biliary

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)

Title
Merck MK-7902-005 LEAP-005-Biliary
Study Title

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)

Site Link
Malignancy
Biliary Tract Cancer, Cholangiocarcinoma; Gallbladder cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd Line
Investigational Agent
Lenvatinib and Pembrolizumab
Drug Class
VEGF-R/FGFR inhibitor and PD-1 inhibitor
PI
Manjari Pandey, MD
Sponsor
Merck Sharp & Dohme Corp
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • 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
Objective

Primary- ORR, safety

Secondary- DCR, DoR, PFS, OS, PK

Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Adenocarcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X