Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
第3相
実施中（募集終了）
NCT03765918
| 対象疾患 | Head and Neck Neoplasms |
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| 相 | 第3相 |
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| スポンサー | Merck Sharp & Dohme LLC |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 714 名 |
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| 介入（薬剤） | Pembrolizumab 200 mg, Radiotherapy 60 Gray, Radiotherapy 66 Gray, Radiotherapy 70 Gray, Cisplatin 100 mg/m^2 |
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| 開始日 | 2018年12月17日 |
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| 完了日 | 2024年7月25日 |
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| 結果公開日 | 2025年8月20日 |
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概要
This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Event-free Survival (EFS)
Up to ~66 months · Months
| Pembrolizumab + Standard of Care (SOC) | 51.8 Months |
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| Standard of Care (SOC) | 30.4 Months |
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| p-value | 0.00411 |
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| Hazard Ratio (HR) | 0.73 (95% CI 0.58–0.92) |
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EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Up to ~66 months · Months
| Pembrolizumab + Standard of Care (SOC) | 59.7 Months |
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| Standard of Care (SOC) | 26.9 Months |
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| p-value | 0.00217 |
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| Hazard Ratio (HR) | 0.66 (95% CI 0.49–0.88) |
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EFS in Participants With PD-L1 CPS ≥1
Up to ~66 months · Months
| Pembrolizumab + Standard of Care (SOC) | 59.7 Months |
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| Standard of Care (SOC) | 29.6 Months |
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| p-value | 0.00140 |
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| Hazard Ratio (HR) | 0.70 (95% CI 0.55–0.89) |
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