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VanderWalde, Ari; Bellasea, Shay L; Kendra, Kari L; Khushalani, Nikhil I; Campbell, Katie M; Scumpia, Philip O; Kuklinski, Lawrence F; Collichio, Frances; Sosman, Jeffrey A; Ikeguchi, Alexandra; Victor, Adrienne I; Truong, Thach-Giao; Chmielowski, Bartosz; Portnoy, David C; Chen, Yuanbin; Margolin, Kim; Bane, Charles; Dasanu, Constantin A; Johnson, Douglas B; Eroglu, Zeynep; Chandra, Sunandana; Medina, Egmidio; Gonzalez, Cynthia R; Baselga-Carretero, Ignacio; Vega-Crespo, Agustin; Garcilazo, Ivan Perez; Sharon, Elad; Hu-Lieskovan, Siwen; Patel, Sapna P; Grossmann, Kenneth F; Moon, James; Wu, Michael C; Ribas, Antoni
Nature medicine, 09/2023, Letnik: 29, Številka: 9Journal Article
In this randomized phase 2 trial, blockade of cytotoxic T-lymphocyte protein 4 (CTLA-4) with continuation of programmed death protein 1 (PD-1) blockade in patients with metastatic melanoma who had received front-line anti-PD-1 or therapy against programmed cell death 1 ligand 1 and whose tumors progressed was tested in comparison with CTLA-4 blockade alone. Ninety-two eligible patients were randomly assigned in a 3:1 ratio to receive the combination of ipilimumab and nivolumab, or ipilimumab alone. The primary endpoint was progression-free survival. Secondary endpoints included the difference in CD8 T cell infiltrate among responding and nonresponding tumors, objective response rate, overall survival and toxicity. The combination of nivolumab and ipilimumab resulted in a statistically significant improvement in progression-free survival over ipilimumab (hazard ratio = 0.63, 90% confidence interval (CI) = 0.41-0.97, one-sided P = 0.04). Objective response rates were 28% (90% CI = 19-38%) and 9% (90% CI = 2-25%), respectively (one-sided P = 0.05). Grade 3 or higher treatment-related adverse events occurred in 57% and 35% of patients, respectively, which is consistent with the known toxicity profile of these regimens. The change in intratumoral CD8 T cell density observed in the present analysis did not reach statistical significance to support the formal hypothesis tested as a secondary endpoint. In conclusion, primary resistance to PD-1 blockade therapy can be reversed in some patients with the combination of CTLA-4 and PD-1 blockade. Clinicaltrials.gov identifier: NCT03033576 .
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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