BREAST: METASTATIC: TNBC: 2nd-3rd Line: LEAP-005-TNBC

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-TNBC
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
Breast, Triple Negative Breast Cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd line or 3rd 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
  • Have received one or 2 prior lines of therapy
  • Must have been treated with taxane and antrhacycline in the past
  • Adjuvant/neoadjuvant tx not considered line of therapy unless progressed within 6 months
  • LDH <2.0 ULN
  • 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
TNBC
Dosing Frequency
Control Agents
Study Protocol
<p>S:\\Research\\Protocols\\Merck MK7902-005 (OTE 4.1.19)\\Protocol</p>
Randomized
No
X