BENITIONSClinical Trial Intelligence

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)

3期 进行中（已停止招募） NCT03765918

适应症Head and Neck Neoplasms
分期3期
申办方Merck Sharp & Dohme LLC
状态进行中（已停止招募）
受试者人数714 人
干预（药物）Pembrolizumab 200 mg, Radiotherapy 60 Gray, Radiotherapy 66 Gray, Radiotherapy 70 Gray, Cisplatin 100 mg/m^2
开始日期2018年12月17日
完成日期2024年7月25日
结果公布日2025年8月20日

摘要

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
Standard of Care (SOC)30.4 Months
p-value0.00411
Hazard Ratio (HR)0.73 (95% CI 0.58–0.92)

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
Standard of Care (SOC)26.9 Months
p-value0.00217
Hazard Ratio (HR)0.66 (95% CI 0.49–0.88)

EFS in Participants With PD-L1 CPS ≥1

Up to ~66 months · Months

Pembrolizumab + Standard of Care (SOC)59.7 Months
Standard of Care (SOC)29.6 Months
p-value0.00140
Hazard Ratio (HR)0.70 (95% CI 0.55–0.89)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。
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