Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 6 of 27 3.3 Visit Windows The allowed visit windows are defined as shown in Table 1. Visits will be analyzed per the eCRF collection. Table 1: Visit Windows Visit Name Allowed window (Cycle Day ± Window) Screening Day -28 to -1 Weeks 2, 3, 5, 6, 7, 9, 11, 13, 14 +/- 2 day Weeks 17, 21, 25, 27 +/- 3 day Week 28 +/- 2 day Weeks 29, 33, 37, 39, 41, 45 +/- 3 day Week 46 +/- 2 day On study Follow -up 28 (+/ -4) days post last dose 42 (+/-4) days post last dose 91 (+/ -7) days post last dose Post Study Follow -up Every 6 months until 5 years Note: Visit days are defined from baseline (Cycle 1, Day 1 visit). Vacinations may have to be dela yed to all ow for recovery of A Es prior to continu ation of va ccine treatment. After the delayed v accination all subsequent vacci nations must be continued within the schedule relat ive to the fi rst vaccinati on pre sented in the flow chart. 3.4 Baseline Unless specified otherwise, baseline measurements will be the most recent value prior to receiving the first dose of study medication. 4.0 ANALYSIS POPULATIONS 4.1 Intent -to-Treat Population The Intent-To- Treat (ITT) Population is defi ned as all subjects who r eceive at least one dose of any of the st udy drugs. This population will be used for safety and efficacy analyses. 4.2 Per-Protocol Population (Clinical Efficacy) The Per-Protocol (PP) Population (Clinical Efficacy) is defined as all subjec ts who received at least 75% of t he sc heduled doses of durval umab and treme limum ab and at least 4 of the 5 BI 13618 49 vacci nations over the first 2 cycl es, as well as, respe ctive dise ase assessments (irRECIST or RECIST, clinical progression or death), w ithout major protocol viol ations. Efficacy analyses will also be presented for PP population. Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 7 of 27 4.3 Per-Protocol Population (DLT Assessments) The Per-Protocol (PP) Population (DLT Assessments) is de fined as follows: • All subjects in the dose escalation who experience a DLT at any time during the DLT Evaluation Period (as defined in Section 3.1.9 of the protocol). • All subjects with no DLT who receive at least 75% of the scheduled doses of durvalumab and tremelimumab and at least 4 of the 5 BI 1361849 vaccinations over the first 2 cycles as well as respective safety assessments without major protocol violations during the DLT Evaluation Period . 5.0 SUBJECT DISPOSITION Subject disposition will be summ arized overall for a ll subject s who entered the study in a disposition table (i.e., signed the informed consent for the study). In addition, the number of subject s in each popula tion (ITT and PP) and subjects that were removed from a popula tion w ill be su mmar ized. The number and propor tion of subject s who complete the study, as well as those who discontinue the study w ill be summar ized along w ith the r eason for discontinua tion. Primary reason for treatment termination include the following criteria: • Withdrawal of consent for furthe r treat ment • Pregn ancy or intent to become pregnant • DLT at any time • Progre ssive dis ease requiri ng alt ernat ive syst emic tre atment • Significant protocol violat ion or noncomplia nce th at, in the opinion of t he Inve stigator or Sponsor, warrants withdrawal • Development of i ntercurr ent, non- cancer-re lated illne sses or complicat ions that prevent either continuat ion of t herapy or regular follow-up • Best medic al interest of the subject (at the dis cretion of t he Inve stigator) Primary reason for study discontinuation include the following criteria: • Best medic al interest of the subject at the disc retion of t he Inve stigator • In itiation of al ternat ive anti cance r therapy (mar keted or investigational) • Withdrawal of consent for all follow-up • Lost to follow-up • Death Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC.