CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,069 enrolled
Drug / intervention
Lenvatinib +3 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histological or cytological confirmation of RCC with clear-cell component
  • ✓Documented evidence of advanced RCC
  • ✓At least 1 measurable target lesion per RECIST 1.1 (LN ≥1.5 cm short axis or non-nodal ≥1.0 cm longest diameter)
  • ✓Karnofsky Performance Status ≥70
Key exclusion· 9
  • ✕Prior systemic anticancer therapy for RCC, including anti-VEGF therapy or investigational agents
  • ✕Active malignancy (other than RCC or treated skin/cervical/bladder carcinoma) within past 24 months
  • ✕Proteinuria ≥1 g/24 h on quantitative assessment
  • ✕Significant cardiovascular disease within 12 months: history of CHF >NHYA Class II, unstable angina, MI, CVA, cardiac arrhythmia with hemodynamic instability, or LVEF below institutional normal

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02811861
NCT02811861Phase 3Active
CompareCT.gov

A Multicenter, 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)

Eisai Inc.·interventional·Posted Jun 23, 2016·Updated Feb 23, 2026

In Brief

A Phase 3 clinical trial evaluating Lenvatinib, Everolimus, and 2 other interventions for Renal Cell Carcinoma. Active but no longer recruiting, targeting 1,069 participants across 183 sites in 20 countries.

Detailed Summary

The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review \[IIR\] using Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Ireland, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Switzerland, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 3Active
20172018201920202021202220232024202520262027
First PostedJun 23, 2016
Enrollment StartOct 13, 2016
Primary CompletionAug 28, 2020
Study CompletionMar 31, 2027
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.0 years ago

Interventions

Lenvatinibdrug

Everolimusdrug

Pembrolizumabdrug

Sunitinibdrug