Safety, tolerability, and potential clinical activity of a glucocorticoid-induced TNF receptor–related protein agonist alone or in combination with nivolumab for patients with advanced solid tumors: A phase 1/2a dose-escalation and cohort-expansion clinical trial
JAMA Nov 15, 2019
Heinhuis KM, Carlino M, Joerger M, et al. - Researchers examined whether patients with advanced solid tumors could safely tolerate the glucocorticoid-induced tumor necrosis factor receptor-related protein agonist BMS-986156 treatment with or without nivolumab. In addition, they assessed the clinical activity of the treatment regimen in these patients. In this global, open-label, phase 1/2a study of BMS-986156 with or without nivolumab, 292 patients 18 years or older with advanced solid tumors and an Eastern Cooperative Oncology Group performance status of 1 or less were enrolled. Outcomes revealed a tolerable safety profile of BMS-986156 therapy in these patients. The safety profile of combination therapy was similar to that of nivolumab. They observed no responses with monotherapy; however, response rates of the combination therapy were comparable to those reported historically with nivolumab (< 15% across tumor types). They identified this study as the largest data set on glucocorticoid-induced tumor necrosis factor receptor–related protein agonism with or without nivolumab. This work yielded no clear evidence demonstrating the efficacy of glucocorticoid-induced tumor necrosis factor receptor–related protein agonism as therapeutic strategy in a broad patient population.
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