28 5.4 Duration of treatment ........................................................................................................... 29 5.4.1 Replacement of patients ...................................................................................................... 29 5.5 Concomitant medication and treatment ............................................................................... 29 6 PHARMACEUTICAL INFORMATION ................................................................................ 31 6.1 Supply of AST -VAC2 vaccine .............................................................................................. 31 6.2 Pharmaceutical data ............................................................................................................ 31 6.2.1 Formulation of AST -VAC2 ................................................................................................... 31 6.2.2 Storage conditions ............................................................................................................... 31 6.2.3 Method of dilution/reconstitution of AST -VAC2 ................................................................... 31 6.2.4 Stability and labelling of the AST -VAC2 .............................................................................. 31 6.2.5 AST-VAC2 administration .................................................................................................... 32 6.2.6 Vein extravasation/accidental spillages ............................................................................... 32 6.3 AST-VAC2 accountability ..................................................................................................... 32 7 INVESTIGATIONS SCHEDULE ......................................................................................... 34 7.1 Pre-treatment evaluations .................................................................................................... 34 7.1.1 Obtaining written informed consent ..................................................................................... 34 7.1.1.1 Pre-screening: HLA testing .............................................................................................. 34 7.1.1.2 Main trial consent and screening ..................................................................................... 34 7.1.2 Evaluations within 28 days prior to administration of AST -VAC2 (Baseline) ...................... 35 7.1.3 Evaluations within 7 days of study enrolment ..................................................................... 36 7.2 Evaluations during the trial ................................................................................................... 36 7.3 Evaluations after vaccination ............................................................................................... 37 7.3.1 Two weeks post vaccination visit ........................................................................................ 37 7.3.2 End of Vaccination vis it ....................................................................................................... 37 7.4 Follow -up .............................................................................................................................. 38 7.4.1 3, 6, 9 and 12 months post first vaccination ........................................................................ 38 7.4.2 15, 18 and 21 month post first vaccination .......................................................................... 38 7.4.3 Two years post first vaccination visit (Ssurvival follow up data collection). ........................ 38 7.4.4 Extended follow up (>2 years to 5 years post first vaccination) .......................................... 39 7.5 Schedule of events .............................................................................................................. 40 8 PHARMACODYNAMIC ASSESSMENTS .......................................................................... 42 8.1 Summary of Pharmacodynamic assessments ..................................................................... 42 8.2 Primary assessments ........................................................................................................... 45 8.3 Secondary assessments ...................................................................................................... 45 8.3.1 Pharmacodynamic blood biomarkers (secondary) .............................................................. 45 8.3.1.1 Identifi cation of peptide specific T cells (Secondary assay 2a) ....................................... 45 8.4 Tertiary/research assessments ............................................................................................ 46 CONFIDENTIAL CRUKD/17/003 Protocol Final 5.0 dated 08Jun2021 Page 5 of 72 EudraCT number : 2016 -002577 -35 Cancer Research UK 9 ASSESSMENT OF SAFETY ............................................................................................... 48 9.1 Investigator Responsibilities .................................................................................................