A synthetic peptide-based, personalized cancer vaccine consisting of patient-specific mutated peptide epitopes, which are immunogenic and unique to the patient's tumor, with potential immunomodulating and antineoplastic activities. Vaccination with the neoantigen-based anti-cancer vaccine NEO-PV-01 stimulates the host immune system to mount a specific and potent cytotoxic T-lymphocyte (CTL) response against tumor cells expressing the neoantigens, which results in tumor cell lysis.