Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
Phase 3
Active, not recruiting
NCT02811861
| Condition | Renal Cell Carcinoma |
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| Phase | Phase 3 |
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| Sponsor | Eisai Inc. |
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| Status | Active, not recruiting |
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| Enrollment | 1,069 participants |
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| Interventions | Lenvatinib, Everolimus, Pembrolizumab, Sunitinib |
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| Start date | Oct 13, 2016 |
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| Completion date | Aug 28, 2020 |
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| Results posted | Sep 24, 2021 |
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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).
Progression-free Survival (PFS) by Independent Imaging Review (IIR)
From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) · months
| Lenvatinib 18 mg Plus Everolimus 5 mg | 14.7 months |
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| Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 23.9 months |
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| Sunitinib 50 mg | 9.2 months |
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| p-value | <0.0001 |
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| Stratified Hazard Ratio | 0.65 (95% CI 0.53–0.80) |
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Open in BENITIONS
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