Lenvatinib plus everolimus or pembrolizumab versus sunitinib in advanced renal cell carcinoma: study design and rationale

Viktor Grünwald, Thomas Powles, Toni K Choueiri, Thomas E Hutson, Camillo Porta, Masatoshi Eto, Cora N Sternberg, Sun Young Rha, Cixin S He, Corina E Dutcus, Alan Smith, Lea Dutta, Kalgi Mody, Robert J Motzer

Research output: Contribution to journalArticlepeer-review

Abstract

AIM: Lenvatinib plus everolimus is approved for the treatment of advanced renal cell carcinoma (RCC) after one prior vascular endothelial growth factor-targeted therapy. Lenvatinib plus pembrolizumab demonstrated promising antitumor activity in a Phase I/II trial of RCC.

METHODS: We describe the rationale and design of the CLEAR study, a three-arm Phase III trial comparing lenvatinib plus everolimus and lenvatinib plus pembrolizumab versus sunitinib monotherapy for first-line treatment of RCC. Eligible patients must have advanced clear cell RCC and must not have received any prior systemic anticancer therapy. The primary end point is progression-free survival; secondary end points include objective response rate, overall survival, safety, health-related quality of life and pharmacokinetics. Biomarker evaluations are included as exploratory end points.

Original languageEnglish
Pages (from-to)929-941
Number of pages13
JournalFuture Oncology
Volume15
Issue number9
DOIs
Publication statusPublished - Mar 2019

Keywords

  • Adult
  • Antibodies, Monoclonal, Humanized/pharmacokinetics
  • Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics
  • Biomarkers, Tumor/analysis
  • Carcinoma, Renal Cell/drug therapy
  • Clinical Trials, Phase III as Topic
  • Everolimus/pharmacokinetics
  • Female
  • Humans
  • Kidney Neoplasms/drug therapy
  • Male
  • Multicenter Studies as Topic
  • Phenylurea Compounds/pharmacokinetics
  • Progression-Free Survival
  • Quality of Life
  • Quinolines/pharmacokinetics
  • Randomized Controlled Trials as Topic
  • Sunitinib/pharmacokinetics
  • Survival Analysis
  • Young Adult

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