Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with everolimus once daily to pediatric participants with recurrent/refractory solid tumors. Phase 2, utilizing Simon’s optimal 2-stage design, will be conducted to estimate the antitumor activity of lenvatinib in combination with everolimus in pediatric participants with selected recurrent/refractory solid tumors including Ewing sarcoma/peripheral primitive neuroectodermal tumor (pPNET), rhabdomyosarcoma, and high grade glioma (HGG) using objective response rate (ORR) at Week 16 as the outcome measure.

Principal Investigator:
Kirov, Ivan

Research Coordinator:
Kathryn Duvall
(714) 509-8646

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  • Clinical Trial Info
  • IRB Number: 170661
  • Sponsor: COG-Esai
  • Protocol Number: ADVL1711
  • NCT Number: NCT03245151
  • Research Type: Adolescents and Young Adults, Recurrent/Refractory Cancer, Solid Tumors
  • Phase: I
  • Status: Active - Open to Enrollment


  • ≥2 years and ≤21 years of age
  • Recurrent or refractory solid tumors (excluding hepatoblastoma and lymphomas), including primary CNS tumors
  • VEGF/VEGFR-targeted or mTOR-targeted therapies:
    – Must not have received prior exposure to lenvatinib
    – May have previously progressed on an mTOR inhibitor
  • No more than 2 prior VEGF/VEGFR-targeted therapies (For Phase 2 only)
  • Standard COG Phase 1 organ function requirements


  • Pulmonary dysfunction
  • Major surgery within 28 days
  • Non-healing wound, unhealed or incompletely healed fracture
  • Nephrotic syndrome
  • Gastrointestinal bleeding or active hemoptysis
  • Thrombotic/ thromboembolic event requiring systemic anticoagulation within 90 days
  • New intracranial hemorrhage of more than punctate size on MRI assessment (HGG)
  • Diagnosis of lymphoma
  • Major blood vessel invasion/infiltration.
  • Untreated CNS metastases
  • Excluded concomitant medications: Corticosteroids (unless on stable dosing), other investigational drugs, other anti-cancer agents, anti-GvHD agents post-transplant, strong CYP1A2 inhibitors w/I past 7 days prior to enrollment, or enzyme-inducing anticonvulsants, and anticoagulants