underarm, ear, mouth etc.) . 6.8 Procedures for Monitoring Subject Compliance All study procedures are to be performed under the direct supervision of the investigator/a licensed healthcare professional at the study site, and thus, no separate procedures will be used to monitor subject compliance. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 55 of 81 CONFIDENTIAL 7 ASSESSMENTS AND PROCEDURES BY STUDY VISI T The timing of the study assessments and procedures are summarized in the SoA (Appendix A ). Note: At the end of the follow up period (that is 12 weeks after each vaccination), ideally one week rest period should be observed before the next vaccination, as described in the SoA. However, up to 1 month rest period is allowed. 7.1 Screening Period ( Visit 1 - Days -21 to Day -1 – Weeks -3 to -1) The following procedures will be performed at the Screening Visit: • Informed consent • Inclusion/exclusion criteria • ECOG performance status • Medical history • Medication history • Complete physical exam • Evaluation of response to first -line therapy • Cancer biopsy for TIL analysis • CT and RECIST assessment • Hematology and blood chemistries • Tumor biomarkers • Urinalysis • Urine pregnancy test • Blood collection for immunogenicity assays 7.2 PolyPEPI 1018 Administration (Visit 2 – Day 1 - Week 0) , (Visit 7 – Day 92 ±2 - Week 13) and (Visit 12 – Day 183 ±2 - Week 26), The following procedures will be performed at Visits 2, 7 and 12: • Concomitant m edications • Complete physical exam • Vaccine site evaluation • Buccal swab • Vaccine administration and 1-hour post-vaccination observation Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 56 of 81 CONFIDENTIAL • Distribute diary • Hematology and blood chemistries (not on Visits 7 and 12) • Tumor biomarkers (not on Visits 7 and 12) • Urinalysis (not on Visits 7 and 12) • Urine Pregnancy Test (not on Visits 7 and 12) • Blood Collection for Immunogenicity Assays (not on Visits 7 and 12) 7.3 Follow-Up Period 7.3.1 Visit 3 (Day 22 - Week 3 ), Visit 5 (Day 64 - Week 9) , Visit 8 (Day 113 ±2 - Week 16), Visit 10 (Day 155 ±2 - Week 22), Visit 13 (Day 204 ±2 - Week 29) and Visit 15 (Day 246 ±2 - Week 35) The following procedure s will be performed at Visits 3, 5, 8, 10, 13 and 15: • Concomitant medications • Targeted physical exam • Vaccine site evaluation • Collect diary • Blood collection for immunogenicity assays 7.3.2 Visit 4 (Day 43 - Week 6 ), Visit 6 (Day 85 - Week 12 ), Visit 9 (Day 134 ±2 - Week 19), Visit 11 (Day 176 ±2 - Week 25), Visit 14 (Day 225 ±2 - Week 32) and Visit 16 (Day 267 ±2 - Week 38) The following procedure s will be performed at Visits 4, 6, 9, 11, 14 and 16: • Concomitant medications • Complete physical exam • Vaccine site evaluation • Collect diary • CT and RECIST assessment (irRECIST assessment for subjects suspected of progression diseases at Visit 4) • Hematology and blood chemistries • Tumor biomarkers • Urinalysis • Urine pregnancy test Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 57 of 81 CONFIDENTIAL • Blood collection for immunogenicity assays • Cancer biopsy for TIL analysis (only at Visit 6) 7.4 Last Visit Every effort will be made to have discontinued, withdrawn, and terminated subjects complete the assessments described for Visit 16 (see Section 7.3.2). If the Last Visit is performed as an unscheduled visit, the assessment results will be recorded with the Last Visit.