Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
Фаза 3
Идёт, набор закрыт
NCT02811861
| Заболевание | Renal Cell Carcinoma |
|---|
| Фаза | Фаза 3 |
|---|
| Спонсор | Eisai Inc. |
|---|
| Статус | Идёт, набор закрыт |
|---|
| Участники | 1,069 участн. |
|---|
| Вмешательство | Lenvatinib, Everolimus, Pembrolizumab, Sunitinib |
|---|
| Дата начала | 13.10.2016 |
|---|
| Дата завершения | 28.08.2020 |
|---|
| Публикация результатов | 24.09.2021 |
|---|
Кратко
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 |
|---|
| Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 23.9 months |
|---|
| Sunitinib 50 mg | 9.2 months |
|---|
| p-value | <0.0001 |
|---|
| Stratified Hazard Ratio | 0.65 (95% CI 0.53–0.80) |
|---|
Открыть в BENITIONS
Открыть на ClinicalTrials.gov
Все исследования
Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.