If yes, this is a positive dechallenge. If no, this is a negative dechallenge. (Note: This criterion is not applicable if: (1) the AE resulted in death or permanent disability; (2) the AE resolved/improved despite continuation of the BMS product; or (3) the trial is a single -dose drug trial); or (4) BMS product(s) is/are only used one time.) Rechallenge Was the subject re -exposed to the BMS product in this study? If yes, did the AE recur or worsen? If yes, this is a positive rechallenge. If no, this is a negative rechallenge. (Note: This criterion is not applicable if: (1) the initial AE resulted in death or permanent disability, or (2) the trial is a single -dose drug trial); or (3) BMS product(s) is/are used only one time). NOTE: IF A RECHALLENGE IS PLANNED FOR AN ADVERSE EVENT WHICH WAS SERIOUS AND WHICH MAY HAVE BEEN CAUSED BY THE BMS PRODUCT, OR IF REEXPOSURE TO THE BMS PRODUCT POSES ADDITIONAL POTENTIAL SIGNIFICANT RISK TO THE SUBJECT, THEN THE RECHALLENGE MUST BE APPROVED IN ADVANCE BY THE U.S. CLINICAL MONITOR AS PER DOSE MODIFICATION GUIDELINES IN THE PROTOCOL. Consistency with Trial Treatment Profile Is the clinical/pathological presentation of the AE consistent with previous knowledge regarding the BMS product or drug class pharmacology or toxicology? The assessment of relationship will be reported on the case report forms /worksheets by an investigator who is a qualified physician according to his/her best clinical judgment, including consideration of the above elements. Record one of the following Use the following scale of criteria as guidance (not all criteria must be present to be indicative of a BMS product relations hip). Yes, there is a reasonable possibility of BMS product relationship. There is evidence of exposure to the BMS product. The temporal sequence of the AE onset relative to the administration of the BMS product is reasonable. The AE is more likely explained by the BMS product than by another cause. No, there is not a reasonable possibility BMS product relationship Subject did not receive the BMS product OR temporal sequence of the AE onset relative to administration of the BMS product is not reasonable OR there is another obvious cause of the AE. (Also entered for a subject with overdose without an associated AE.) Protocol Version 8.0. September 19 , 2018 Page | 55 8.0 STATISTICAL ANALYSIS PLAN 8.1 Statistical Analysis Plan Summary 8.1.1 Study Design This is a single institution, phase II study. The primary endpoint is disease control rate (DCR). Secondary endpoints include response rate, progression- free survival (PFS), overall survival (OS). Biomarkers correlative studies are also included. 8.2 Statistical Analysis Plan 8.2.1 Sample size A sample size of 39 achieves 91% power to detect a difference of 0.20 using a one -sided binomial test. The target significance level is 0.100. The actual significance level achieved by this test is also 0.100. These results assume that the population proportion under the null hypothesis is 0.50. 8.2.2 Analysis of Primary and Secondary Endpoints The disease control (DCR=CR+PR+SD) rates, overall response rate (ORR=CR+PR) will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by group. The PFS, defined as time from enrollment (eligible date) t o date of progression/death, whichever happens first, or censor at last clinical follow -up date. The OS, defined as the time from study enrollment (eligible date) to death from any cause. Both PFS and OS will be summarized utilizing the K -M method. 8.2.3 Safety Analysis - Toxicity Toxicity from this trial will be collected on all study drug treated patients. Simple descriptive statistics will be utilized to display the data on toxicity seen from both groups. Toxicities will be assessed using NCI CTCAE v.4.1. 8.2.4 Laboratory Correlative Studies Results from the different correlative variables will be reported descriptively. Cox proportional hazards regression models will be employed to explore the association of various such variables with DCR, PFS and OS . The Fisher exact/Chi -square test and logistic regression will be considered to study the association between various disease or patient characteristics and FFPE archival tissue studies ( protein expressions by IHC ). In some cases, due to the small sample size, these analyses may have low sensitivity for the predictive impact of the biomarkers, and will be exploratory by necessity.