9 2 STUDY Objective ................................................................................................................... 9 2.1 Primary Objective ............................................................................................................ 9 2.2 Secondary Objective ........................................................................................................ 9 2.3 Exploratory Objective ...................................................................................................... 9 3 Study Design ......................................................................................................................... 10 3.1 Overall Pl an .................................................................................................................... 10 3.1.1 Study Treatment ...................................................................................................... 10 3.1.2 Treatment Administered ......................................................................................... 10 3.2 Study Population ............................................................................................................ 11 3.3 Randomization, Stratification and Blinding ................................................................... 11 3.3.1 Randomization and Stratification ........................................................................... 11 3.3.2 Blinding................................................................................................................... 12 3.4 Study Assessments ......................................................................................................... 12 4 Sample Size Determination ................................................................................................... 18 5 study endpoints ..................................................................................................................... 18 5.1 Efficacy Endpoints ......................................................................................................... 18 5.1.1 Primary Efficacy Endpoint ..................................................................................... 18 5.1.1.1 Progression -free Survival (PFS) ...................................................................... 18 5.1.1.2 Overall Survival (OS) ........................................................................................ 19 5.1.2 Secondary Efficacy Endpoint s ................................................................................ 20 5.1.2.1 Time to Next Treatment (TTNT) ........................................................................ 20 5.1.2.2 Distant Metastasis -Free Survival (DMFS) .......................................................... 20 5.1.2.3 Objective Response Rate (ORR) ......................................................................... 20 5.1.2.4 Quality of Life (QOL) - EQ-5D-5L and EQ -5D-Y ............................................. 21 5.1.3 Exploratory Efficacy Endpoint ............................................................................... 21 5.2 Safety Endpoints ........................................................................................................... 21 5.2.1 Adverse Events ....................................................................................................... 21 5.2.2 Clinical Laboratory Evaluations ............................................................................. 21 05FPRF Immune Design C orp. IMDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 4 / 36 5.2.3 Vital Signs ............................................................................................................... 22 5.2.4 Electrocardiogram (ECG) .......................................................................................