Trials / Active Not Recruiting
Active Not RecruitingNCT02811861
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,069 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | |
| DRUG | Everolimus | |
| DRUG | Pembrolizumab | |
| DRUG | Sunitinib |
Timeline
- Start date
- 2016-10-13
- Primary completion
- 2020-08-28
- Completion
- 2027-03-31
- First posted
- 2016-06-23
- Last updated
- 2026-02-23
- Results posted
- 2021-09-24
Locations
183 sites across 20 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Ireland, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02811861. Inclusion in this directory is not an endorsement.