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Nivolumab alone and with ipilimumab in previously treated metastatic urothelial carcinoma: CheckMate 032 nivolumab 1 mg/kg plus ipilimumab 3 mg/kg expansion cohort results

Journal of Clinical Oncology Jul 03, 2019

Sharma P, et al. - In CheckMate 032, an open-label, multicohort study of patients with unresectable locally advanced or metastatic urothelial carcinoma (mUC), treatment comprised nivolumab 3 mg/kg monotherapy every 2 weeks (NIVO3), nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks (NIVO3+IPI1), or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks (NIVO1+IPI3). In this work, the expanded NIVO1+IPI3 cohort and extended follow-up for the NIVO3 and NIVO3+IPI1 cohorts were reported. In this phase I/II multicenter study, 78 patients with platinum-pretreated mUC were administered NIVO3 (minimum follow-up, 37.7 months), 104 were administered NIVO3+IPI1 (minimum follow-up, 38.8 months), and 92 were administered NIVO1+IPI3 (minimum follow-up, 7.9 months). NIVO3 exhibited sustained antitumor activity alone and in combination with ipilimumab with longer follow-up. The greatest antitumor activity was provided by NIVO1+IPI3 among all regimens, with a manageable safety profile. This study only supports the further study of NIVO1+IPI3 in mUC, but illustrates the potential benefit of immunotherapy combinations in this disease.
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