Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])
3期
已完成
NCT03517449
| 适应症 | Endometrial Neoplasms |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Eisai Inc. |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 827 人 |
|---|
| 干预（药物） | Pembrolizumab, Lenvatinib, Paclitaxel, Doxorubicin |
|---|
| 开始日期 | 2018年6月11日 |
|---|
| 完成日期 | 2022年3月1日 |
|---|
| 结果公布日 | 2021年11月17日 |
|---|
摘要
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants
Up to approximately 27 months · Months
| Lenvatinib 20 mg + Pembrolizumab 200 mg | 6.6 ± 5.6 Months |
|---|
| Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel | 3.8 ± 3.6 Months |
|---|
| p-value | < 0.0001 |
|---|
| Hazard Ratio (HR) | 0.60 (95% CI 0.50–0.72) |
|---|
PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants
Up to approximately 27 months · Months
| Lenvatinib 20 mg + Pembrolizumab 200 mg | 7.2 ± 5.7 Months |
|---|
| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 3.8 ± 3.6 Months |
|---|
| p-value | < 0.0001 |
|---|
| Hazard Ratio (HR) | 0.56 (95% CI 0.47–0.66) |
|---|
Overall Survival (OS) in pMMR Participants
Up to approximately 43 months · Months
| Lenvatinib 20 mg + Pembrolizumab 200 mg | 18.0 Months |
|---|
| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 12.2 Months |
|---|
| p-value | < 0.0001 |
|---|
| Hazard Ratio (HR) | 0.70 (95% CI 0.58–0.83) |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。