Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma
Phase 2
Completed
NCT02296684
| Condition | Cancer of Head and Neck, Head and Neck Cancer, Neoplasms, Head and Neck, Carcinoma, Squamous Cell of Head and Neck |
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| Phase | Phase 2 |
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| Sponsor | Washington University School of Medicine |
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| Status | Completed |
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| Enrollment | 67 participants |
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| Interventions | MK-3475 (neoadjuvant), Surgery, Intensity modulated radiation therapy, Image-guided radiation therapy, Cisplatin |
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| Start date | Mar 25, 2015 |
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| Completion date | Apr 5, 2022 |
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| Results posted | May 11, 2023 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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