Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 18 of 27 • ECG data will be presented in a data listing. 9.5 ECOG Performance ECOG perfomance will be evaluated on a 6 -point scale from grade 0 -5. ECOG PS a ssessments will be summ arized overa ll by time point utilizing des criptive s tatistics. ECOG performance status will be taken except on Cycle 2 Day 8, Cycle 4 Day 8, Cycle 7 Day 22, Cycle 12 Day 8, and the post study follow-up. • ECOG PS assessments will also by summarized as categorical variable by timepoint with the n and percentage being displayed for e ach arm or indication- specific cohort. 9.6 Physical Examinations A full phy sical exa mination will be perf ormed at screening/ baseline. There will also be targ eted physical examinations at other time points except on Cycle 2 Day 8, Cycle 4 Day 8, Cycle 7 Day 22, Cycle 12 Day 8, and the post study follow-up. • Continuous and categorical variables at baseline and various timepoints will be summarized using descriptive statistics. • Clinically significant changes from baseline to postbaseline time points will be summarized using descriptive statistics. 9.7 Pregnancy Testing Serum p regnancy testing (when applica ble) is required pri or to dosi ng up to 1 week before start of treatment. Pregnancy testing is also done on Day 1 of Cycles 1, 3, 5, 7, 9, 11, and On Study Follow-up Days +28 and +91 Days. Also, all s ubjects of childbe aring potential who w ithdraw from st udy must have a serum pregnancy test done at the End of Study vis it, unle ss it w as done within 7 days prior to the End of Study Visi t. • T he results of pregnancy testing (Yes/No) will be summarized for every applicable timepoint with the n and percentage being displayed for each arm or cohort. 10.0 EXPLORATORY ANALYSIS Pharmacodynamics analyses on biologic activity related to study treatment will be performed for all subjects who receive at least one dose of any study drug. These analyses will not be performed by Advanced Clinical but will be conducted by the Sponsor’s designated pharmacodynamics experts/vendors and the results will be summarized in a report which will be included as an appendix to the Clinical Study Report. Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 19 of 27 Per Protocol Amendment 9.1, some of the biological assessment tests will no longer be applicable. Hence, some blood sample collections for immune monitoring were discontinued as indicated in the study flow chart. 11.0 STATISTICAL/ANALYTICAL ISSUES 11.1 Handling of Dropouts or Missing Data In the dose evaluation phase, subjects who are not fully evaluable for DLT per section 4.1.2 of the protocol may be replaced. Subjects who are not fully evaluable for the PFS rate and ORR may be replaced. All ava ilable da ta will be pre sented on the da ta listin gs as collected. Algorithms for imputing partial or missing dates related to AEs and prior/concomitant medications are shown below in Table 4 . Table 4 Imputation Rules for Partially Missing Dates Variable Missing Day Missing Day, Month Missing Day, Month, Year Date of Last Therapy /Date of In itial Diagnos is Assign 1 Assign January 1 if prior to date of inform ed co nsent, otherwise use date of inform ed consent Missing (do not impu te) Adverse Event/Medication Start Date Assign first day of month unless it is t he month of first dose of study medication. Otherwis e, assign d ate of first dose of study med ication. Assign January 1 unles s the year is year of firs t dose of study medicatio n Otherwis e, assign d ate of first dose of stud y medication. Assign date first dose of study medication. Adverse Event/Medication End Date Assign the last day of the month or end of stud y date, whichev er is earlier. Assign December 31 or end of study d ate, whichev er is earlier. If ongoing, end date is missi ng.