Subjects who do not start any post -study treatment intervention will be censored at their last known date of being alive (same as OS). 5.1.2.2 Distant Metastasis -Free Survival (DMFS) DMFS is defined as the time from randomization to evidence of a new distant metastasis not documented at time of randomization: [DMFS = a new distant metastasis documented date – randomization date + 1 ]. Subjects who do not have any new distant metastasis will be censored at their last tumor assessment . 5.1.2.3 Objective Response Rate (ORR) The ORR is defined as the percent of subjects who achieve either CR or PR per RECIST 1.1 by investigator’s assessment as best response: [ORR = (CR+PR)/ total number of subjects]. The best overall response is determined once all the data for the subject is known. No confirmatory measurement for CR or PR is required in this study. The best overall response is defined as the best response (in the order of CR, PR, SD, and PD) among all overall responses recorded from randomiz ation until the last radiographic tumor assessment (for example, a subject who has SD at first assessment, PR at second assessment, and PD on last assessment has a best overall response of PR) . All tumor assessments after the first PD will be ignored. ORR by independent radiological review , if required, will be the supportive endpoints and its definition and censorship are similar to the ORR by investigator’s assessment defined above. 05FPRF Immune Design Corp. I MDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 21 / 36 5.1.2.4 Qual ity of L ife (QOL ) - EQ-5D-5L and EQ -5D-Y QOL will be evaluated using the EuroQol 5- Dimension 5 Level (EQ -5D-5L) for subjects ≥18 years of age and for subjects 12 to <18 years of age . EQ-5D-5L The EQ -5D-5L consists of the EQ -5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions: mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 leve ls: no problems, slight problems, moderate problems, severe problems, and extreme problems. The digits for 5 dimensions can be combined in a 5- digit number describing the respondent’s health state. EQ-5D-5L health states, defined by the EQ -5D-5L descripti ve system, will be converted into a single index value. The index values, presented in country specific value sets, are a major feature of the EQ -5D instrument. EQ -5D-5L scoring will be based on EQ -5D-5L User Guide 2015 (UK Version 2, please refer to A ppendix 2 for index score weights ). 5.1.3 Exploratory Efficacy Endpoint Intratumoral and peripheral blood anti -NY-ESO -1 immune changes biomarker analysis will be included in a Supplemental Statistical Analysis Plan (SSAP) . This includes anti-NY-ESO -1 immune response and histologic and molecular changes in peripheral blood and tumor tissue and their association with clinical outcomes. 5.2 Safety Endpoints 5.2.1 Adverse Events A treatment -emergent adverse event (TEAE) is defined as any AE that newly appeared or worsened in severity following initiation of the study treatment administration until 30 days after last dose of the study treatment. In additional, all study treatment related AEs are treated as TEAE. Medical Event of Interest (MEOI) is defined as s elected non- serious AE s are classified as MEOIs, refer to protocol section 6.4.7.5 for more details. Immune -mediated event -- 5.2.2 Clinical Laboratory Evaluations Clinical laboratory evaluations include hematology, serum chemistry , urinalysis , coagulation and viral tests .