A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)
3상
완료
NCT04199104
| 대상 질환 | Head and Neck Squamous Cell Carcinoma |
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| 임상 단계 | 3상 |
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| 스폰서 | Merck Sharp & Dohme LLC |
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| 상태 | 완료 |
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| 참여자 수 | 511 명 |
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| 중재(약물) | Lenvatinib, Pembrolizumab |
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| 시작일 | 2020년 2월 5일 |
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| 완료일 | 2023년 5월 30일 |
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| 결과 공개일 | 2024년 7월 16일 |
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요약
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Up to ~ 37 months · Percentage of participants
| Pembrolizumab + Lenvatinib | 46.9 Percentage of participants |
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| Pembrolizumab + Placebo | 27.5 Percentage of participants |
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| p-value | 0.0000019 |
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| point estimate | 19.3 (95% CI 11.2–27.3) |
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Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).
Up to ~ 37 months · Months
| Pembrolizumab + Lenvatinib | 7.0 Months |
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| Pembrolizumab + Placebo | 2.8 Months |
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| p-value | 0.0001129 |
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| Hazard Ratio (HR) | 0.68 (95% CI 0.55–0.83) |
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Overall Survival (OS)
Up to ~ 37 months · Months
| Pembrolizumab + Lenvatinib | 15.0 Months |
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| Pembrolizumab + Placebo | 17.9 Months |
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| p-value | 0.8819584 |
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| Hazard Ratio (HR) | 1.15 (95% CI 0.91–1.45) |
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BENITIONS에서 보기
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