Nature communications · 2024
Cryoablation and post-progression immune checkpoint inhibition in metastatic melanoma: a phase II trial.
СтатьяКлиническое исследование II фазыПоддержка исследования: вне правительства СШАПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Mooradian Meghan J, Fintelmann Florian J, LaSalle Thomas J, Simon Judit, Graur Alexander, Muzikansky Alona, Mino-Kenudson Mari, Shalhout Sophia, Kaufman Howard L, Jenkins Russell W, Lawrence Donald, Lawless Aleigha, Sharova Tatyana, Uppot Raul N, Fang Jacy, Blaum Emily M, Gonye Anna L K, Gushterova Irena, Boland Genevieve M, Azzoli Christopher, Hacohen Nir, Sade-Feldman Moshe, Sullivan Ryan J
Аннотация
Image-guided percutaneous cryoablation is an established minimally invasive oncologic treatment. We hypothesized that cryoablation may modify the immune microenvironment through direct modulation of the tumor, thereby generating an anti-tumor response in tumors refractory to immune checkpoint inhibition (ICI). In this non-randomized phase II single-center study (NCT03290677), subjects with unresectable melanoma progressing on ICI underwent cryoablation of an enlarging metastasis, and ICI was continued for a minimum of two additional cycles. The primary endpoints were safety, feasibility and tumor response in non-ablated lesions. From May 2018 through July 2020, 17 patients were treated on study. The study met its primary endpoints with the combination strategy found to be safe and feasible with an objective response rate of 23.5% and disease control rate of 41% (4 partial response, 3 stable disease). Our data support further study of this synergistic therapeutic approach.