Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma
2期
已完成
NCT02296684
| 适应症 | Cancer of Head and Neck, Head and Neck Cancer, Neoplasms, Head and Neck, Carcinoma, Squamous Cell of Head and Neck |
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| 分期 | 2期 |
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| 申办方 | Washington University School of Medicine |
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| 状态 | 已完成 |
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| 受试者人数 | 67 人 |
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| 干预（药物） | MK-3475 (neoadjuvant), Surgery, Intensity modulated radiation therapy, Image-guided radiation therapy, Cisplatin |
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| 开始日期 | 2015年3月25日 |
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| 完成日期 | 2022年4月5日 |
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| 结果公布日 | 2023年5月11日 |
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摘要
The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches.
Locoregional Recurrence Rates in Cohorts 1 and 2
Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose) · Participants
| Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | 2 Participants |
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| Cohort 2: Neoadjuvant MK-3475 | 2 Participants |
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Distant Failure Rate in Cohorts 1 and 2
Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose) · Participants
| Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | 3 Participants |
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| Cohort 2: Neoadjuvant MK-3475 | 1 Participants |
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Rate of Major Pathologic Treatment Effect in Cohort 1
At the time of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose) · Participants
| Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | 20 Participants |
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| Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | 8 Participants |
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| Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | 8 Participants |
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