2.1.1.5 Men or Women; Age >18 years. 2.1.1.6 ECOG performance status < 2 (see APPENDIX A: Performance Status Criteria). 2.1.1.7 Adequate hematologic function at screening, as follows: Absolute neutrophil count (ANC) ≥1 x 109/L; Hemoglobin ≥ 9 g/dL; Platelets ≥ 75,000/microliter. 2.1.1.8 Adequate renal and hepatic function at screening, as follows: Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR Measured or calculated creatinine clearance ≥ 40 mL/min for participant with creatinine levels > 1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl); Bilirubin ≤ 1.5 x ULN OR in subjects with Gilbert’s syndrome, a total bilirubin ≤ 3.0 x ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN, unless liver metastases are present, then values must be ≤ 3 x ULN). 2.1.1.9 The effects of the immunotherapies (PRGN-2009 vaccine and M7824) on the developing human fetus are unknown.