Among patients with previously treated, locally advanced, or metastatic urothelial carcinoma, nivolumab monotherapy was associated with a durable clinical response as well as a manageable safety profile, according to a study published in The Lancet Oncology.1

Researchers led by Padmanee Sharma, MD, of the MD Anderson Cancer Center in Houston, Texas, conducted a phase 1/2, multicenter, open-label study ( Identifier:

NCT01928394) of 86 patients with metastatic urothelial carcinoma. Patients were treated with nivolumab monotherapy every 2 weeks until disease progression or treatment discontinuation, with a primary endpoint of objective response. Seventy-eight patients had received at least 1 dose of treatment.

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With a minimum follow-up of 9 months, it was found that objective response was achieved in 19 of the 78 patients (24.4%). Grade 3 to 4 treatment-related adverse events occurred in 17 patients (22%).

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Serious adverse events were found in 37 of the 78 patients (46%), and 8 patients (10%) had a serious adverse event judged to be treatment-related. Two patients died due to treatment-related adverse events.


  1. Sharma P, Callahan MK, Bono P, et al. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. Lancet Oncol. 2016 Oct 9. doi: 10.1016/S1470-2045(16)30496-X [Epub ahead of print]