Appendix 5. Revised Recommendations of The International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia .... 262 SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 16 SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 17 List of Tables Table 1 Definition of Adequate Organ Function ........................................................ 121 Table 2 Treatment for Pembrolizumab ....................................................................... 135 Table 3 Description of Investigational Products ........................................................ 137 Table 4 Structural Formula of Galinpepimut-S .......................................................... 138 Table 5 Dose Modification and Toxicity Management Guidelines for Immune-related AEs Associated with Pembrolizumab ........................................................... 154 Table 6 Pembrolizumab Infusion Reaction Dose Modification and Treatment Guidelines ...................................................................................................... 158 Table 7 Pembrolizumab Product Description……………………………………….167 Table 8 Schedule of Assessments…………………………………………………...174 Table 9 Laboratory Analyses………………………………………………………..200 Table 10 Imaging and Treatment After First Radiological Evidence of Progressive Disease……………………………………………………………………...205 Table 11 Statistical Design Performance for CRC or OvC Cohorts of 20 Patients…..209 Table 12 Statistical Design Performance for SCLC Cohort of 20 Patients…………..210 Table 13 Statistical Design Performance for TNBC and AML Cohorts of 15 Patients……………………………………………………………………..210 SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 18 Table 14 Decision Criteria for a Stop or Go Decision in Each Cohort at the Planned Sample Size…………………………………………………………………216 List of Figures Figure 1 Kaplan-Meier Plot for Overall Survival by Disease Group ............................ 75 Figure 2 Study 10-143 (AML Patients): Kaplan-Meier Plot for Median Disease-Free Survival ............................................................................................................ 79 Figure 3 Study 10-143 (AML Patients): Kaplan-Meier Plot for Median Overall Survival ............................................................................................................ 79 Figure 4 Study 10-143 (AML Patients): Kaplan-Mei er Plot for Median EFS from First Galinpepimut-S Administration ...................................................................... 80 Figure 5 Study 10-143 (AML Patients): Kaplan-Meier Plot for Median Overall Survival from First Galinpepimut-S Administration ....................................... 80 Figure 6 Study 10-143 (AML Patients): Kaplan-Meier Plot for Median Disease-Free Survival of Patients < 60 Years of Age ........................................................... 81 Figure 7 Study 10-143 (AML Patients): Kaplan-Meier Plot for Median Overall Survival of Patients < 60 Years of Age ........................................................... 81 Figure 8 Study 10-143 (AML Patients): Kaplan-Meier Plot for Median Disease-Free Survival of Patients ≥ 60 Years of Age ........................................................... 82 Figure 9 Study 10-143 (AML Patients): Kaplan-Meier Plot for Median Overall Survival of Patients ≥ 60 Years of Age ........................................................... 82 SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 19 Figure 10 Study MCC-15025 (AML Patients in CR2): Kaplan-Meier Plot for Median Overall Survival in Galinpepimut-S-treated Patients who Received >2 Vaccine Inoculations (N=10) versus Contemporaneously Treated Historical Matched Controls (N=15) ................................................................................ 86 Figure 11 Study 15-247 (Ovarian Cancer Patients): Kaplan-Meier Plot for Median Progression-Free Survival Showing the Landmark 1-year PFS Rate in the ITT Population ....................................................................................................... 90 Figure 12 Study Design………………………………………………………………..114 Figure 13 Overall Treatment Administration Schedule……………………………….141 Figure 14 Imaging and Treatment for Clinically Stable Patients Treated with Pembrolizumab after First Radiologic Evidence of PD Assessed by Investigator…………………………………………………………………207 SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 20 Protocol Synopsis SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 21 Protocol Number: SLS17-201/MK3475-770 Title: A Phase 1/2 Study of Galinpepimut-S in Combination with Pembrolizumab (MK-3475) in Patients with Selected Advanced Cancers Protocol version Study Amendment # 1.1 1.0 Sponsor: SELLAS Life Sciences Group, Inc. 15 West 38th Street; 10th Floor New York, NY 10018 United States of America Telephone: +1-917-438-4352 FAX: +1-917-634-3413 Study Phase: 1/2 Study Sites: Up to 20 centers in the United States.