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)

3상 진행 중(모집 완료) NCT03765918

대상 질환	Head and Neck Neoplasms
임상 단계	3상
스폰서	Merck Sharp & Dohme LLC
상태	진행 중(모집 완료)
참여자 수	714 명
중재(약물)	Pembrolizumab 200 mg, Radiotherapy 60 Gray, Radiotherapy 66 Gray, Radiotherapy 70 Gray, Cisplatin 100 mg/m^2
시작일	2018년 12월 17일
완료일	2024년 7월 25일
결과 공개일	2025년 8월 20일

요약

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-value	0.00411
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-value	0.00217
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-value	0.00140
Hazard Ratio (HR)	0.70 (95% CI 0.55–0.89)

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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