Personnel monitoring this study will not be affiliated in a ny way with the trial conduct. 8 STATISTICAL CONSIDERATIONS STATISTICAL HYPOTHESIS 8.1.1 Primary Efficacy EndpointThe primary objectives of this tria l is to determine the clinical response rate in patients with metastatic melanoma or epithelial cancers who receive this dendritic cell vaccine. The objective response rate (res ponses/evaluable patients) is t he measurable endpoint, and it will be of interest to determine if it exceeds 10% and is co nsistent with 25%. 8.1.2 Secondary Efficacy EndpointThe secondary objectives are to de termine the safety of the vac cine and to determine whether treatment administrati on can increase the quantity and quality of circulating antigen-specific T cells. SAMPLE SIZE DETERMINATION Assays to assess quality and quan tity of the vaccine induced ce lls will include Eliza and Elispot assays assessing reactivity to the mutated peptide compared to the non-mutated peptide. Patients will be enrolled int o 2 individual cohorts; melanoma and common epithelial canc ers. For each of the 2 cohorts, the study will be conducted using a phase II opt imal design19(Simon R, Controlled Clinical Trials 10:1-10, 1989). T he objective will be to determine if the vaccine is able to be associated with a clinical res ponse rate that can rule out 5% (p0=0.05) in favor of a modest 20% PR + CR rate (p1=0.20).In patients in each of the two c ohorts, the following design wi ll be used. For each cohort, with alpha=0.05 (5% probability of accepting a poor therapy) and bet a=0.10 (10% probability of rejecting a good therapy,), initia lly 21 evaluable patients wil l be enrolled. If 0 or 1 of the 21 patients experiences a clinical response, then no further patie nts will be enrolle d. If 2 or more of the first 21 evaluable patient s enrolled have a clinical respon se, then accrual w ill continue until a total of 41 evaluable p atients have been enr olled. As it may tak e several weeks to determine if a patient has experienced a clini cal response, a temporary pause of up to 6 months in the accrual to the trial may be necessary to ens ure that enrollment to the sec ond stage is warranted. If 2 to 4 of the 41 have a clinical response, t hen this will be considered inadequate for further investigation. If 5 or more of 41 patients have a clinical response, then this will indicate that this strategy provides a new approach that may be worthy of further considera tion. Under the null hypothesis (5% response rate), the probab ility of early termination is 72% . A total of up to 86 patients may be required (allowing up to 2 in evaluable patients per cohort). Provided that about 1- 2 patients per month will be able to be e nrolled onto this trial, approximately 6 years may be needed to accrue the maximum number of required patients. Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 38However, as adequate responses to proceed to the second stage of accrual may not occur, the trial may end up accruing as few as 21 patients in each cohort. POPULATION FOR ANALYSES Modified intention to t reat analysis datase t. Patients who rece ive adequate treatment (defined as the administration of peptide pul sed antigen presenting cells) will be considered evaluable and included in the statistical analyses STATISTICAL ANALYSES 8.4.1 General Approach Descriptive statistical analyses will be performed without any formal hypothesis testing. 8.4.2 Analysis of the Primary EndpointsFor each cohort, the clinical response rate (PR+ CR/number of ev aluable subjects) will be determined and reporte d along with the corresponding 95% two-si ded confidence interval. 8.4.3 Analysis of the Secondary Endpoint(s)To determine whether treatment a dministration can increase the quantity and quality of circulating antigen-specific T cells, by measuring the reactivit y of circulating cells against the immunizing peptides in Elispot and 41BB upregulation assays. 8.4.4 Safety AnalysesSafety will be monitored by iden tifying the type and severity o f any adverse events. The fraction of patients who experience a DL T will be iden tified, with infor mation reported about the number and grade of each type of DLT identified. 8.4.5 Baseline Descriptive StatisticsNot applicable. 8.4.6 Planned Interim AnalysesAs noted in Section 8.2, results after the first sta ge of a Simon optimal two-stage de sign in each cohort will be examine d to determine if the minimum number of r esponses has been obtained. 8.4.7 Sub-Group AnalysesThere are no planned analyses base d on demographic characterist ics since the power to do subgroup analyses would be limited and make interpretation diff icult. 8.4.8 Tabulation of individua l Participant Data None planned.