A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
第2相
実施中(募集終了)
NCT03698019
| 対象疾患 | Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Mucosal Melanoma |
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| 相 | 第2相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 313 名 |
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| 介入(薬剤) | Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab, Therapeutic Conventional Surgery |
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| 開始日 | 2019年2月15日 |
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| 完了日 | 2022年9月1日 |
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| 結果公開日 | 2023年11月21日 |
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概要
This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.
Two-Year Event-Free Survival Rate
2 years · percentage of participants
| Arm I (Adjuvant Pembrolizumab) | 49 percentage of participants |
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| Arm II (Adjuvant and Neoadjuvant Pembrolizumab) | 72 percentage of participants |
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| p-value | 0.004 |
| Hazard Ratio (HR) | 0.64 |
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