GBM: 2nd Line: Pembro-Lenvatinib: LEAP-005-GBM

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-GBM
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
Glioblastoma Multiforme, GBM, malignant glioma
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
  • Histologically confirmed WHO Grade IV glioblastoma
  • Failed initial systemic tx
  • At least 3 weeks from prior surgical resection
  • At least 6 months from previous radiation unless new area of enhancement outside the 80% isodose line of originial radiation field
  • At least 6 weeks from prior mAbs
  • Has not required escalting doses of steroids or had progression of neurologic symptoms in last 2 weeks
  • No carcinomatous meningitis
  • No extracranial disease
  • No multifocal tumor
  • No recurrent tumor greater than 6cm
  • No intra- or pertumoral hemorrhage greater than grade 1
  • Measurable Disease per RECIST and RANO
  • 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 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
GBM
Dosing Frequency
Control Agents
Study Protocol
<p>S:\\Research\\Protocols\\Merck MK7902-005 (OTE 4.1.19)\\Protocol</p>
Randomized
No
X