Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
NCT02811861 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1069
Last updated 2026-02-23
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).
Conditions
Interventions
- DRUG
- DRUG
- DRUG
- DRUG
-
Sunitinib
Sponsors & Collaborators
- collaborator INDUSTRY
-
Eisai Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-13
- Primary Completion
- 2020-08-28
- Completion
- 2027-03-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Belgium
- Canada
- Czechia
- France
- Germany
- Greece
- Ireland
- Israel
- Italy
- Japan
- Netherlands
- Poland
- Russia
- South Korea
- Spain
- Switzerland
- United Kingdom
Study Locations
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