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are\n                      <jats:italic>T<\/jats:italic>\n                      umors (DART) studied the efficacy of ipilimumab combined with nivolumab across multiple rare tumor types. We report the results of the pancreatic neuroendocrine neoplasm (PNEN) cohort.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Experimental design<\/jats:title>\n                    <jats:p>Treatment consisted of ipilimumab 1\u2009mg\/kg intravenously every 6 weeks with nivolumab 240\u2009mg intravenously every 2 weeks. The primary endpoint was overall response rate (ORR) (Response Evaluation Criteria In Solid TumorsRECIST V.1.1). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and toxicity. Clinical benefit rate (includes ORR plus stable disease (SD)&gt;6 months was examined. Correlative studies were performed. The trial was conducted by the National Cancer Institute\/Southwest Oncology Group Early Therapeutics and Rare Cancers Committee and opened at &gt;1,000 sites.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>19 patients with PNEN were enrolled. The median number of lines of prior therapy was 2 (range: 0\u20134). The ORR was 11% (2\/19 patients); the clinical benefit rate (CBR; stable disease &gt;6\u2009months+partial response+complete response), 26% (5\/19). The median PFS was 3 months; median OS, 24 months. The longest PFSs were 26 (intermediate grade PNEN), 31 (low grade) and 39+months (intermediate grade). The most common toxicities were fatigue (47% of patients) and aspartate aminotransferase (AST) elevation (32%); the most common grade 3\/4 immune-related adverse event (AE) was AST (32%) and bilirubin elevation (26%), with no grade 5 events. Programmed death-ligand 1 expression by chromogenic immunohistochemistry (N=12 patients assessed) did not associate with ORR; tumor mutation burden (TMB) was high in three patients; one of the two patients with partial remission (PFS=26 months) had high TMB (150 mutations\/mb). Peripheral effector memory T-cell activation (N=11 patients assessed by cytometry by time-of-flight with 5 having longitudinal analysis) was associated with response, though the number of patients evaluated was limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Low-dose ipilimumab plus nivolumab demonstrated an 11% ORR and 26% CBR (includes SD&gt;6 months) in patients with refractory PNEN, with durable benefit (&gt;2 years) in 3 (16%) patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02834013\">NCT02834013<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  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