18 Protocol Synopsis .................................................................................................................... 20 List of Abbreviations ............................................................................................................... 58 1 Introduction ...................................................................................................................... 68 1.1 Galinpepimut-S Background .................................................................................. 68 1.1.2. Galinpepimut-S Clinical Studies ............................................................................ 73 1.1.2.1. Phase 1 Clinical Experience with Galinpepimut-S (Study 06-085) .................... 73 1.1.2.2.2. Study MCC-15025 (AML Patients) ................................................................. 84 1.1.2.2.3. Study 15-247 (Ovarian Cancer Patients) ........................................................ 87 1.2 Pembrolizumab Background .................................................................................. 91 1.2.1. General ................................................................................................................... 91 1.2.2. Pharmaceutical and Therapeutic Background ........................................................ 91 1.2.3. Pre-clinical and Clinical Trials .............................................................................. 92 1.2.4. Justification for Pembrolizumab Dose ................................................................... 93 1.3. Study Rationale ......................................................................................................... 94 1.3.1. General ...................................................................................................................