Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

Official Title

A Multicentre, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma (CLEAR)


This is a multicentre, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.

Trial Description

Primary Outcome:

  • Progression-free survival (PFS) by independent review
Secondary Outcome:
  • Objective response rate (ORR)
  • Overall survival (OS)
  • Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
  • Number of participants who discontinued treatment due to toxicity
  • Time to treatment failure due to toxicity
  • Health-Related Quality of Life (HRQoL) scores
  • PFS on next-line of therapy (PFS2)
  • PFS by investigator assessment
  • Model-predicted clearance for lenvatinib and everolimus
  • AUC for lenvatinib and everolimus

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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