For example, for a DLT that occurs in 10% of patients, there is a greater than 90% probability of escalating. Conversely, for a DLT that occurs with a rate of 70%, the probability of escalating is 3%. It is assumed that dose escalation occurs wi th either 0/3 or 1/6 patients with DLTs. Table 1. Probability of Escalating Dose True underlying DLT rate 10% 20% 30% 40% 50% 60% 70% 80% 90% Probability of escalating dose 0.91 0.71 0.49 0.31 0.17 0.08 0.03 0.009 0.001 Probabilities of testing sequential doses can be calculated as the 3+3 escalation rules are predefined. For example the probability of escalating to a third dose level is 0.64 under the assumption that DLTs occur in 10% and 20% of patients respectively in the first dose and the second dose. The probability of escalating to a third dose is only 0.35 if DLTs occur in 20% and 30% of patients respectively in the first dose and the second dose tested. 4.3.Sample Size Determination The exact sample size of the 3+3 designs in the Phase 1Part A (Dose Escalation) cannot be pre-specified because of the dynamic feature of the design. The number of patients to be enrolled in the study will depend upon the observed safety profile, which will determine the number of patie nts at each dose level ( eg, 3or 6) and the number of dose levels explored. Typically, at least 3 patients will be treated at each regimen dose level. Dose cohorts with an acceptable safety profile (0/3 or 1/6 patients with DLTs) may be expanded up to N=15 to further assess safety, immune response, pharmacokinetics, and pharmacodynamics. Decisions to enroll additional patients at dose levels already cleared for safety will be based on clinical judgment of the investigators and the sponsor considering all evaluable safety, immunoresponse, and/or pharmacodynamics data. The estimated sample size for Part A would be 24-48 patients and will be dependent on the safety profile observed. The sample size for Cohort 1B (AdC68 + pDNA + treme 80 mg SC for BCR patien ts who had no prior therapy) was determined clinically rather than statistically. Twenty patients were enrolled in that cohort to provide preliminary efficacy, safety, PK and biomarker data for this regimen. For Cohort 3B (AdC + pDNC + treme 80 mg SC + PF- 0689159 300 mg SC. for patients with mCRPC whose disease has progressed despite novel hormonal treatment), 18patients Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 9were enrolled. The main efficacy endpoint for this cohort will be objective response rate (ORR) based on RECIST version 1.1, the key supp ortive efficacy endpoint will be radiographic progression -free survival (rPFS). There are no hypothesis tests for these endpoints.