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])
Phase 3
Completed
NCT03517449
| Condition | Endometrial Neoplasms |
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| Phase | Phase 3 |
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| Sponsor | Eisai Inc. |
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| Status | Completed |
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| Enrollment | 827 participants |
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| Interventions | Pembrolizumab, Lenvatinib, Paclitaxel, Doxorubicin |
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| Start date | Jun 11, 2018 |
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| Completion date | Mar 1, 2022 |
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| Results posted | Nov 17, 2021 |
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Summary
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 |
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| Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel | 3.8 ± 3.6 Months |
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| p-value | < 0.0001 |
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| Hazard Ratio (HR) | 0.60 (95% CI 0.50–0.72) |
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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 |
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| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 3.8 ± 3.6 Months |
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| p-value | < 0.0001 |
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| Hazard Ratio (HR) | 0.56 (95% CI 0.47–0.66) |
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Overall Survival (OS) in pMMR Participants
Up to approximately 43 months · Months
| Lenvatinib 20 mg + Pembrolizumab 200 mg | 18.0 Months |
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| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 12.2 Months |
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| p-value | < 0.0001 |
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| Hazard Ratio (HR) | 0.70 (95% CI 0.58–0.83) |
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