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Axitinib in combination with toripalimab, a humanized immunoglobulin G4 monoclonal antibody against programmed cell death-1, in patients with metastatic mucosal melanoma: An open-label phase IB trial

Journal of Clinical Oncology Nov 17, 2019

Sheng X, Yan X, Chi Z, et al. - By conducting this single-center, phase IB trial enrolling 33 patients, researchers tested toripalimab (a humanized immunoglobulin G4 monoclonal antibody against programmed cell death-1) with regard to its safety and preliminary efficacy when administered in combination with the vascular endothelial growth factor receptor inhibitor axitinib in patients with advanced melanoma, including cases with chemotherapy-naïve mucosal melanomas (88%). Until proved disease progression, unacceptable toxicity, or voluntary withdrawal, the patients were given toripalimab at 1 or 3 mg/kg through intravenous infusion every 2 weeks, in combination with axitinib 5 mg orally twice a day, in a dose-escalation and cohort-expansion study. Findings revealed the good tolerability as well as the promising antitumor activity of toripalimab plus axitinib in patients with treatment-naïve metastatic mucosal melanoma. The use of this combination therapy as a standard of care requires its validation in a non-Asian population in a randomized phase III trial because this study included all Asian patients.
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