Purpose: The management of endometrial carcinoma no longer amenable to treatment with surgery or radiation has not improved significantly with modern chemotherapy. Alternative therapeutic options are desperately needed. Experimental Design: We describe 2 heavily pretreated patients with recurrent disease refractory to surgery, radiation and chemotherapy treated with the anti-PD1 immune check-point inhibitor nivolumab. Results: Patient # 1 harbored an ultra-mutated (Mutation Load/MB = 117.3, total mutations = 4660) tumor driven by mutation in the exonuclease domain of the DNA polymerase gene. Patient # 2 harbored a hyper-mutated tumor (Mutation Load/MB = 33.5, total mutations = 1037) due to a germinal MSH6 gene mutation. Both patients demonstrated a remarkable clinical response to the anti-PD1 immune check-point inhibitor nivolumab. Patients' clinical responses remain unchanged at the time of the writing of this report with no grade 3 or higher side-effects reported to date. Conclusions: Anti-PD1 inhibitors represent a novel treatment option for recurrent/metastatic ultra/hypermutated human tumors refractory to salvage treatment.
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