Trial to Assess Safety and Efficacy of Lenvatinib in Combination With Everolimus in Participants With Renal Cell Carcinoma

Official Title

A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment


Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate [ORR] at 24 weeks [ORR24W]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any ≥ Grade 3 adverse events (AEs) in the first 24 weeks after randomization).

Trial Description

Primary Outcome:

  • Objective response rate (ORR) at Week 24 (ORR24W) as assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1
  • Percentage of participants with intolerable Grade 2 or any ≥ Grade 3 treatment-emergent adverse events (TEAEs) within 24 weeks after randomization (as of the Week-24 time point)
Secondary Outcome:
  • Progression-free survival (PFS)
  • ORR as assessed by the investigator according to RECIST 1.1 at the end of treatment
  • Percentage of participants with any treatment-emergent adverse event (TEAE) and percentage of participants with any serious TEAE
  • Percentage of participants who discontinue treatment due to toxicity
  • Time to treatment failure due to toxicity
  • Apparent clearance
  • Area under the plasma drug concentration-time curve (AUC)
  • Population PK-derived AUC
  • Overall survival (OS)
  • Health-Related Quality of Life (HRQoL) assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) scores
  • HRQoL assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 scores
  • HRQoL assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) questionnaire scores
  • PFS after next line of treatment (PFS2)

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Canadian Cancer Society

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