{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"}],"units":"Participants"}],"description":"Will evaluate the proportion of n=8 evaluable patients in the expansion cohort experiencing a dose-limiting toxicity. Toxicity rates will be described using upper 1-sided 95% Jeffreys binomial confidence intervals.","groups":[{"description":"Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously\n\nDecitabine: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nNivolumab: Given IV\n\nPoly ICLC: Given SC\n\nThe study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.","id":"OG000","title":"Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)"}],"paramType":"NUMBER","populationDescription":"All treated and eligible patients","reportingStatus":"POSTED","timeFrame":"Up to 180 days","title":"Proportion or Participants Experiencing a Dose-limiting Toxicity","type":"PRIMARY","unitOfMeasure":"percentage of participants"}