BENITIONSClinical Trial Intelligence

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
第2相
スポンサーNational Cancer Institute (NCI)
ステータス実施中(募集終了)
参加者数313 名
介入(薬剤)Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab, Therapeutic Conventional Surgery
開始日2019年2月15日
完了日2022年9月1日
結果公開日2023年11月21日

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
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)72 percentage of participants
p-value0.004
Hazard Ratio (HR)0.64

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