24 3.1.6 Rationale for Dose Le vel Regimen and Route of Administration ............................ 26 3.1.7 Phase II Portion ......................................................................................................... 26 Protocol Stopping Rules ............................................................................................... 27 Drug Administration ..................................................................................................... 27 Baseline Evaluations..................................................................................................... 28 3.4.1 Within 7 Days Prior to the First Vaccination (Day 0) .............................................. 28 3.4.2 Within 2 Days Prior to the First Vaccination (Day 0) .............................................. 28 On-Study Evaluations ................................................................................................... 28 3.5.1 Within 2 Days Prior to Each Subsequent Vaccination (Days 14, 28, & 42 (± 5 days)) 28 3.5.2 After Each Vaccination ............................................................................................. 29 Post-Treatment (Follow-up) Evaluations ...................................................................... 29 3.6.1 First Follow-up Evaluation ....................................................................................... 29 3.6.2 Subsequent Follow-up Evaluations........................................................................... 29 Study Assessment Calendar .......................................................................................... 31 Criteria for Removal from Protocol Therapy and Off-Study Criteria .......................... 33 3.8.1 Criteria for Removal from Protocol Therapy............................................................ 33 3.8.2 Off-Study Criteria ..................................................................................................... 33 3.8.3 Off Protocol Therapy and Off-Study Procedure ....................................................... 33 4 CONCOMITANT MEDICAT IONS/MEASURES ...................................................... 34 5 BIOSPECIMEN COLLECTION .................................................................................. 35 Samples Sent to Figg Lab ............................................................................................. 35 Samples Sent to Surgery Bran ch Cell Production Facility ........................................... 35 Sample Collection Schedule ......................................................................................... 35 Immunological Testing ................................................................................................. 36 Sample Storage, Tracking, and Disposition For Surgery Branch Cell Production Facility ...................................................................................................................... ................ 36 Sample Storage, Tracking, and Disposition for Figg Lab ............................................ 36 5.6.1 Sample Data Collection ............................................................................................ 36 5.6.2 Sample Storage and Destruction ............................................................................... 37 6 DATA COLLECTION AND EVALUATION ............................................................. 37 Data Collection ............................................................................................................. 37 6.1.1 Exclusions to Routine Adverse Event Recording ..................................................... 38 Data Sharing Plans ........................................................................................................ 38 6.2.1 Human Data Sharing Plan ......................................................................................... 38 6.2.2 Genomic Data Sharing Plan ...................................................................................... 38 Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 6 Response Criteria .......................................................................................................... 38 6.3.1 Disease Parameters ...................................................................................................