Patients who have no valid and determinate assay result related to any proposed analysis will be excluded from the pharmacodynamics analysis set. 5.6.Evaluable Population As a consequence of its mechanisms of action, PrCa VBIR may require time after administration to induce a prostate cancer -specific immune response and subsequent tumor response. Therefore, tumors in patients treated with cancer vaccines may show early progression followed by subsequent response, therefore, supportive analysis populations may be based on the evaluable population (EP) which willconsist of all patients in the mITT Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 10population who have been dosed through Cycle 1 Day 57, Day 85 or Day 113(Day 113 is Cycle 2Day 1). To implement this, 3 sub-populations will be created : EP C1D57, EP C1D85, and EP C2D1. EP C1D57 will include all patients who have received all assigned doses at least until C1D57 . EP C1D85 and EP C2D1 are defined in the same manner. Additionally, tumor response and PD analyses may be repeated in the mITT population in patients who have no major protocol deviations during the first and second treatment cycle . 5.7.Treatment Misallocations For patients with errors in treatment allocation the following ap proach will be followed: If a patient was: Enrolled but not treated, then they will be reported under their enrolled treatment group for demographic analy ses onl y. These patients will be excluded from the immunogenicit y, efficacy and safet y analyses as the actual treatment is missing. Enrolled but took incorrect treatment, then they will be reported under their enrolled treatment group for efficacy analy sesbased on mITT ,excluded from anal yses based on PP, but will be reported under the treatment they a ctuall y received for all safet y, PK, immune responses, and anti- tremelimumab or anti -PF-0680159 immunogenicity analyses. 5.8. Protocol Deviations Major protocol deviation swillbe determined on an ongoing basis per medical data review. Any major protocol deviation will prevent the patient from being included in the per -protocol population. A full list of major protocol deviation s will be compiled prior to database closure. Once the final list of major protocol deviations is determined the per -protocol population flag will be updated. 6.ENDPOINTS AND COVARI ATES 6.1.Part A Primary Endpoint Incidence and grade of treatment- emergent adverse events including DLTs as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). 6.2.Part A Secondary Endpoint Immune response including T cells specific to the three selected prostate cancer tumor- antigens. T cell immune response will bedetermined as the frequency of IFN-spot forming cells (SFC) /million peripheral blood mononuclear cells (PBMC) in response to Prostate -Specific Membrane Antigen ( PSMA ), Prostate Stem Cell Antigen (PSCA )and Prostate -Specific Antigen (PSA)as measured intheIFN- ELISPOT assay . For analy sis in the IFN -ELISPOT assay , the PSMA antigen will Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 11be divided into three sub regions (peptide pools) for which the IFN- γspot forming cells/million PBMCs will be reported separately (ie, 5 reported values) or by antigen (3 PSMA summed) or all pooled. The PSCA and PSA assays will each be analyzed as a single antigen (ie, 1 reported value for each antigen). ELISPOT assay reported variables, by the Lab, are specified and listed in the respective CSAP document. •Antibody response specific to the PSMA antigen (Geometric Means and Seroconversion): will be determined as the titer (U/mL) of serum IgG antibodies elicited against the PSMA antigen as measured in the Luminex-based assay. •Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 4.03) and timing. •Tremelimumab single-dose PK parameters , including the maximum concentration (C max), time to maximum concentration (T max), and area under the concentration versus time curve (AUC) from time zero to the last quantifiable time point prior to the second tremelimumab dose (AUC last) and if data permit, AUC from time zero extrapolated to infinity (AUC 0-inf); and trough concentrations after multiple dosing (Ctrough). •PF-06801591 single-dose PK parameters , including C max, Tmax, AUC last, and if data permit, AUC inf; and C trough after multiple dosing. •Incidence and titers of ADA and neutralizing antibodies against tremelimumab. •Incidence and titers of ADA and neutralizing antibodies against PF-06801591. 6.3. Part A Exploratory Endpoints •Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Objective Response Rate (ORR) and radiographic Progression-Free Survival (PFS). •Antitumor response based on total measurable tumor burden as assessed by the Immune-Related Response Criteria (irRECIST) and irPFS. •Bone outcome according to Prostate Cancer Working Group 3 (PCWG3) criteria. CCI Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 12 6.4. Part B Primary Endpoint •Incidence and grade of treatment-emergent adverse events including DLTs as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). 6.5. Part B Secondary Endpoint •For Cohort 3B: Objective response rate (ORR) and duration of response, as assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. •For Cohort 3B: Antitumor response and tumor control duration based on total measurable tumor burden as assessed by the Immune-Related Response Criteria Derived from RECIST 1.1 (irRECIST). •For Cohort 3B: Bone outcome according to Prostate Cancer Working Group 3 (PCWG3) criteria. •For Cohort 3B: Radiographic Progression-Free Survival (rPFS) by RECIST 1.1, irRECIST and PCWG3 Criteria in participants with mCRPC. •PSA-50 response rate and duration of response.