Future oncology (London, England) · 2023
ARTISTRY-7: phase III trial of nemvaleukin alfa plus pembrolizumab vs chemotherapy for platinum-resistant ovarian cancer.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Herzog Thomas J, Hays John L, Barlin Joyce N, Buscema Joseph, Cloven Noelle G, Kong Lynn R, Tyagi Nidhi Kumar, Lanneau Grainger S, Long Beverly J, Marsh Robert L, Seward Shelly M, Starks David C, Welch Stephen, Moore Kathleen N, Konstantinopoulos Panagiotis A, Gilbert Lucy, Monk Bradley J, O'Malley David M, Chen Xiwei, Dalal Rita, Coleman Robert L, Sehouli Jalid
Аннотация
Standard single-agent nonplatinum chemotherapy provides only modest benefit in a small proportion of patients with platinum-resistant/-refractory ovarian cancer, with objective response rates of 6-20% and progression-free survival of ≈3-4 months. Nemvaleukin alfa (nemvaleukin, ALKS 4230) is a novel cytokine designed to capture and expand the therapeutic potential of high-dose interleukin-2 (IL-2) while mitigating its associated toxicity issues. Nemvaleukin preferentially activates cytotoxic CD8+ T cells and natural killer cells with minimal, non-dose-dependent effects on CD4+ regulatory T cells. The global, randomized, open-label, phase III ARTISTRY-7 trial will compare efficacy and safety of nemvaleukin plus pembrolizumab with chemotherapy in patients with platinum-resistant ovarian cancer. The primary end point is investigator-assessed progression-free survival. Clinical Trial Registration: GOG-3063; ENGOT-OV68; NCT05092360 (ClinicalTrials.gov).