TRIAL TREATMENT ............................................................................................................. 51 4.1 Identity of the investigational product ....................................................................... 51 4.1.1 Packaging an d labelling of the investigational produc t ................................... 52 4.1.1.1 TG01 ............................................................................................................... 52 4.1.1.2 GM-CSF .......................................................................................................... 52 4.1.1.3 Chemotherapy ................................................................................................. 52 4.1.2 Storage, issue, and return of investigational product ...................................... 52 4.2 Assignment of patients to treatment .......................................................................... 53 4.3 Preparation of trial treatment ..................................................................................... 53 4.3.1 TG01 ............................................................................................................... 53 4.3.2 GM-CSF .......................................................................................................... 53 4.3.3 Chemotherapy ................................................................................................. 53 4.3.4 DTH................................................................................................................. 54 CT TG01 -01 Version v10.0 27 June 2018 Confidential 3 / 87 4.4 Dosage and administration of trial treatment ............................................................ 54 4.4.1 GM-CSF and TG01 dose and administration .................................................. 54 4.4.2 Chemotherapy ................................................................................................. 55 4.4.3 DTH................................................................................................................. 55 4.4.4 Chemotherapy dosing criteria ......................................................................... 56 4.5 Management of Toxicit y ........................................................................................... 56 4.5.1 Anticipated toxicity and management ............................................................. 56 4.5.2 Chemotherapy dose interruption/reduction ..................................................... 57 4.5.3 GM-CSF and TG01 dose interruption ............................................................. 58 4.6 Concomitant medication ............................................................................................ 59 4.7 Treatment compl iance ............................................................................................... 59 5. TRIAL MEASUREMENTS A ND ENDPOINTS ................................................................... 59 5.1 Primary endpoint ....................................................................................................... 59 5.2 Secondary endpoints .................................................................................................. 59 5.3 Exploratory endpoints ............................................................................................... 59 5.4 Screening assessments ............................................................................................... 60 5.4.1 Inform ed consent ............................................................................................. 60 5.4.2 Patient eligibility ............................................................................................. 60 5.4.3 Demographic data, medical history ................................................................. 60 5.4.4 Special examinations ....................................................................................... 60 5.4.5 Physical examination ...................................................................................... 61 5.4.6 Laboratory safety measurements ..................................................................... 61 5.5 Assessments during treatment phase ......................................................................... 61 5.6 Immunological effect ................................................................................................. 65 5.7 CT-scan ..................................................................................................................... 66 5.8 Efficacy measurements and endpoints ...................................................................... 66 5.8.1 Immunology response ..................................................................................... 66 5.8.2 Disease- free survival ....................................................................................... 66 5.8.3 O verall survival ............................................................................................... 66 5.8.4 KRAS status expression .................................................................................. 67 5.8.5 CA19.9 levels ..................................................................................................