QUILT-2.025 NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using a Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects W/ Previously Treated Cancers.

Exclusion Criteria

• •Pre-treatment Phase: Tissue Procurement and Development of Vaccine
• •1\. Unable or unwilling to attend required study visits and return for adequate follow-up, as required by this protocol.
• •Treatment Phase:
• •1. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
• •2. Active autoimmune disease requiring systemic immunosuppressive treatment within 4 weeks prior to enrollment on this study (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma, ankylosing spondylitis, scleroderma, multiple sclerosis). A history of inactive autoimmune disease or autoimmune disease not requiring systemic immunosuppressive therapy within 4 weeks prior to study enrollment is allowed.
• •3. History of organ transplant requiring immunosuppression.
• •4. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• •5. Inadequate organ function, evidenced by the following laboratory results:
• •1. ANC \< 1,000 cells/mm\^3.
• •2. Platelet count \< 75,000 cells/mm\^3.
• •3. Uncorrectable grade 3 anemia (hemoglobin \< 8 g/dL).
• •4. Total bilirubin \> ULN (unless the subject has documented Gilbert's syndrome).
• •5. AST (SGOT) or ALT (SGPT) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases).
• •6. Alkaline phosphatase levels \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \> 10 × ULN in subjects with bone metastases).
• •7. Serum creatinine \> 2.0 mg/dL or 177 μmol/L.
• •6. Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
• •7. Positive results of screening test for HIV.
• •8. Current chronic daily treatment (continuous for \> 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
• •9. Known hypersensitivity to any component of the study medication(s).
• •10. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with the study treatment. Anti-androgen and anti-estrogen medications are allowed.
• •11. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to initiation of treatment on this study, except for testosterone-lowering therapy in men with prostate cancer.
• •12. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• •13. Concurrent participation in any interventional clinical trial.
• •14. Pregnant and nursing women.