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Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-mesothelin (CRS-207) With or Without Nivolumab in Patients with Pancreatic Cancer.
Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-mesothelin (CRS-207) With or Without Nivolumab in Patients with Pancreatic Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research Tsujikawa, T. n., Crocenzi, T. n., Durham, J. N., Sugar, E. A., Wu, A. A., Onners, B. n., Nauroth, J. M., Anders, R. A., Fertig, E. J., Laheru, D. A., Reiss, K. n., Vonderheide, R. H., Ko, A. H., Tempero, M. A., Fisher, G. A., Considine, M. n., Danilova, L. n., Brockstedt, D. G., Coussens, L. M., Jaffee, E. M., Le, D. T. 2020Abstract
Two studies in previously-treated metastatic pancreatic cancer have been completed combining GVAX pancreas vaccine (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated Listeria monocytogenes expressing mesothelin). In the current study, we compared Cy/GVAX followed by CRS-207 with (Arm A) or without nivolumab (Arm B).Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease were randomized 1:1 to receive treatment on Arm A or Arm B. The primary objective was to compare overall survival (OS) between the arms. Additional objectives included assessment of progression-free survival, safety, tumor responses, CA19-9 responses and immunologic correlates.Ninety-three patients were treated (Arm A, 51; Arm B, 42). The median OS in Arms A and B were 5.9 (95% CI, 4.7, 8.6) and 6.1 (95% CI, 3.5, 7.0) months, respectively, with a hazard ratio 0.86 (95% CI, 0.55, 1.34). Objective responses were seen in three patients using immune-related response criteria (4%, 2/51, Arm A; 2%, 1/42, Arm B). The
View details for DOI 10.1158/1078-0432.CCR-19-3978
View details for PubMedID 32273276