A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Phase 2
Active, not recruiting
NCT03698019
| Condition | Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Mucosal Melanoma |
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| Phase | Phase 2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 313 participants |
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| Interventions | Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab, Therapeutic Conventional Surgery |
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| Start date | Feb 15, 2019 |
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| Completion date | Sep 1, 2022 |
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| Results posted | Nov 21, 2023 |
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Summary
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 |
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| Hazard Ratio (HR) | 0.64 |
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Open in BENITIONS
View on ClinicalTrials.gov
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