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/LEAP-010)-China Extension
3상
완료
NCT05523323
| 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 | 112 명 |
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| 중재(약물) | Lenvatinib, Pembrolizumab |
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| 시작일 | 2020년 10월 30일 |
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| 완료일 | 2023년 8월 25일 |
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| 결과 공개일 | 2024년 10월 18일 |
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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 approximately 33 months · Percentage of participants
| Pembrolizumab + Lenvatinib | 39.3 Percentage of participants |
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| Pembrolizumab + Placebo | 9.8 Percentage of participants |
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| p-value | 0.0002014 |
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| Estimate difference | 29.5 (95% CI 14.0–43.9) |
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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 approximately 33 months · Months
| Pembrolizumab + Lenvatinib | 7.0 Months |
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| Pembrolizumab + Placebo | 1.5 Months |
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| p-value | 0.0000037 |
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| Hazard Ratio (HR) | 0.34 (95% CI 0.21–0.55) |
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Overall Survival (OS)
Up to approximately 33 months · Months
| Pembrolizumab + Lenvatinib | 10.9 Months |
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| Pembrolizumab + Placebo | 11.9 Months |
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| p-value | 0.30933 |
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| Hazard Ratio (HR) | 0.86 (95% CI 0.49–1.54) |
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BENITIONS에서 보기
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