A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer

Exclusion Criteria

• •Patients with deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) phenotype
• •Patient has a known tumor mutation burden \<1 non-synonymous mutations/megabase
• •Known DNA Polymerase Epsilon mutations
• •Patients with known BRAFV600E mutations
• •Bleeding disorder or history of significant bruising or bleeding following IM injections or blood draws
• •Immunosuppression anticipated at time of study treatment
• •History of allogeneic tissue/solid organ transplant
• •Active or history of autoimmune disease or immune deficiency
• •Patient with symptomatic or actively progressing central nervous system (CNS) metastases, carcinomatous meningitis, or has been treated with whole brain radiation
• •History of other cancer within 2 years with the exception of neoplasm that has undergone potentially curative therapy
• •Any severe concurrent non-cancer disease that, in the judgment of the Investigator, would make the patient inappropriate for the current study
• •Active tuberculosis or recent (\<2 weeks) clinically significant infection, evidence of active hepatitis B or hepatitis C, or known history of positive test for HIV
• •History of pneumonitis requiring systemic steroids for treatment (with the exception of prior resolved in-field radiation pneumonitis)
• •Myocardial infarction within previous 3 months, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure (Class III or IV).
• •Pregnant, planning to become pregnant, or nursing.