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Background. Advanced germ cell tumors are associated with poor prognosis. We investigated the role of pembrolizumab in patients with advanced germ cell tumors.
Methods. We analyzed a prespecified cohort of an openlabel, phase II clinical trial in which patients with advanced germ cell tumors were treated with pembrolizumab (200 mg) intravenously every 21 days. The endpoints of the study were the non-progression rate (NPR) at 27 weeks, safety, and tolerability. An NPR >20% was considered successful and worthy of further pursuit.
Results. From August 2016 to February 2018, 12 patients (10 men, 2 women) were treated (median age, 35 years [range, 22–63 years]; median number of prior systemic therapies, 3.5 [range, 2–7]; median number of metastatic sites, 3 [range, 2–8]). Overall, pembrolizumab was well tolerated…