Care should be taken to carefully monitor the patient’s hematologic status throughout the course of the trial. Use of hematopoietic growth factors to ameliorate hematologic toxicity is at the discretion of the physician investigator and should be in accordance with the American Society of Clinical Oncologists (ASCO) guidelines. 3.4.2 Nelipepimut-S and GM-CSF In our previous trials evaluating Nelipepimut-S + GM-CSF, approximately 18% of patients experienced robust local reactions (>100mm) or greater than or equal to grade 3 local or systemic reactions greater than or equal to grade 2 hypersensitivity reactions. 32 Dose Reductions of Vaccine. Toxicities observed with the vaccine are attributable to the GM-CSF. For patients experiencing robust local reactions (>100mm x 100mm) or greater than or equal to grade 3 local or systemic reactions greater than or equal to grade 2 hypersensitivity reactions, the dose of GM-CSF will be reduced by 50% for subsequent inoculations. If subsequent reactions occur necessitating dose reduction, the GM-CSF dose will continue to be reduced serially by 50%. For example, GM-CSF dose would first be reduced from 250 mcg to 125 mcg, with subsequent reductions to 62.5 mcg, then 30 mcg and finally 0 mcg. If 19 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 dose reduction of GM-CSF is inadequate in limiting reactions, the nelipepimut-S dose (if applicable) will then be reduced by 50%. Dose reductions will continue for booster inoculations in the same manner as performed in the PVS, except for patients who underwent multiple dose reductions in the primary vaccine series, who will begin booster inoculations with an initial GM-CSF dose of 125 mcg. In our prior trial, approximately 5% of patients developed delayed urticarial reactions (generalized urticaria 10-14 days after booster inoculation). This was not seen during the PVS. The majority of these patients were readily treated with anti-histamines or oral steroids and most continued with subsequent booster inoculations. If dose reduction is performed for hypersensitivity reactions (generalized urticaria), antihistamines may be used before or after subsequent inoculations. If urticaria persists with the use of anti-histamines and oral steroids, or intravenous steroids are required, or hospitalization is required, or in the opinion of the Principal Investigator, further inoculations will be discontinued. 3.5 Compliance with laws and regulations This study will be conducted in accordance with current U.S.