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)
Фаза 3
Завершено
NCT04199104
| Заболевание | Head and Neck Squamous Cell Carcinoma |
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| Фаза | Фаза 3 |
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| Спонсор | Merck Sharp & Dohme LLC |
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| Статус | Завершено |
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| Участники | 511 участн. |
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| Вмешательство | Lenvatinib, Pembrolizumab |
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| Дата начала | 5.02.2020 |
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| Дата завершения | 30.05.2023 |
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| Публикация результатов | 16.07.2024 |
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Кратко
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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