BENITIONSClinical Trial Intelligence

A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma

Фаза 2 Идёт, набор закрыт NCT03698019

ЗаболеваниеAcral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Mucosal Melanoma
ФазаФаза 2
СпонсорNational Cancer Institute (NCI)
СтатусИдёт, набор закрыт
Участники313 участн.
ВмешательствоBiospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab, Therapeutic Conventional Surgery
Дата начала15.02.2019
Дата завершения1.09.2022
Публикация результатов21.11.2023

Кратко

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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