5. International Conference on Harmonization (ICH, 1996) E6 Guideline for Good Clinical Practice 6. International Conference on Harmonization (ICH, 1997) E8 Guideline: General Considerations for Clinical Trials 7. Medi cal Dic tionary f or Regula tory Activities (MedDRA), Version 20. 8. World Health Organization (WHO) Drug Dictionary (WhoDrugDDEB2_201703). 15.0 RECORD RETENTION Records related to the activities listed in this plan will be retained according to AC SOP AD-005. Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 23 of 27 16.0 CHANGE HISTORY Version Date Description of Changes 0.1 07OCT2019 First draft version 0.2 10OCT2019 Current version. First version delivered to LICR by AC 0.3 01NOV 2019 Revised by AC , Sent to LICR 0.4 14NOV2019 Version 0.3 Revised by AC, Version 0.4 s ent to LICR 1.0 12DEC2019 Final version 1.1 20AUG2020 1. Section 7 revised to better expound on BOR, PFS, DOR 2. Clinical Laboratory Data (Section 9.2 revised to reflect intended analysis 3. Section 9.3 (Urinalysis) deleted as it is covered in Section 9.2 4. Section 3.4 inserted to explain baseline measurements 2.0 15SEP2020 Alignment with protocol Amendment version 9.1 (01SEP20 20) Revisions to Section 7 as updated in version 1.1 and to align with mock shells, 2.1 02DEC2020 Phase 2 tumor types in Section 9.2 changed to Arm A and Arm B (irRECIST or RECIST, clinical progression or death) inserted in the definition of per protocol analysis population to emphasize disease assessments methods 3.0 09DEC2020 Final version Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 24 of 27 17.0 APPENDICES 17.1 Appendix A: Study Flowchart Cycle 5 Cycle 6 Cycle Day 1 8 (±2) 15 (±2) 1 (±2) 8 (±2) 15 (±2) 1 ( ±2) 15 (±2) 1 (±2) 8 (±2) 1 (±3) 1 (±3) Cumulative Study DayUp to 1 month before Tx s ta rt1 8 15 29 36 43 57 71 85 92 113 141 Treatment Durvalumab (Arms A and B) X X X X X X Tremelimumab (Arm B) X X X X BI 1361849 - 6 components (Arms A and B) X X X X X X X X X X Disease Staging (date/stage at 1st diagnosis and at study entry) X Disease Assessment by ir REC IST/REC ISTa X X X Study Procedures and Examinations Eligibility Assessment and Informed Consent (IC)hX Demogr aphics (incl. DoB; sex ; height; r ace; ethnicity) X M edical histor y X P hy sical Ex am (incl.