Treatments Administered ..................................................................................... 133 SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 11 5.2.1. Galinpepimut-S ...................................................................................... 133 5.2.2. Montanide ISA 51 VG ........................................................................... 134 5.2.3. Sargramostim (GM-CSF) ...................................................................... 135 5.2.4. Pembrolizumab ...................................................................................... 135 5.3. Identity of Investigational Drug Product .............................................................. 137 5.3.1. Galinpepimut-S ...................................................................................... 137 5.3.2. Montanide ISA 51 VG ........................................................................... 139 5.3.3. Sargramostim (GM-CSF) ...................................................................... 140 5.3.4. Pembrolizumab ...................................................................................... 140 5.3.5. Overall Treatment Schedule .................................................................. 140 5.3.6. Toxicities ............................................................................................... 141 5.3.6.1. Dose-Limiting Toxicities ....................................................................... 144 5.3.6.2. AML-Specific Dose-Limiting Toxicities .............................................. 149 5.3.6.3. Dose Modification and Toxicity Management Guidelines for Pembrolizumab ...................................................................................... 153 5.3.7. Toxicity Management of Injection-reactions Related to Galinpepimut-S ............................................................................................................... 161 5.3.8. Definition of an Overdose of Investigational Agents for This Protocol 162 5.3.9. Toxicity Management of Known/Expected AEs Associated with the Continuing Use of Hypomethylating Agents (HMAs) in Patients Enrolled in the AML Arm ..................................................................... 163 5.3.9.1. Toxicity Profile and Dose Modifications for Azacitidine (AML Patients) (Vidaza ® US Prescribing Information; Appendix 12.1) ........................ 163 5.3.9.2. Toxicity Profile and Dose Modifications for Decitabine (AML Patients) (Dacogen ® US Prescribing Information; Appendix 12.2) ..................... 165 5.4.