Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer

Exclusion Criteria

• •For Vaccine Production Stage:
• •Patients with micro-satellite instable (MSI)-high disease
• •Patients with known tumor mutational burden (TMB) \<1 non-synonymous mutations/megabase
• •Patients with known DNA Polymerase Epsilon mutations
• •Known exposure to chimpanzee adenovirus (ChAd) within the prior 6 months, plan to receive a ChAd-based vaccine in the next 6 months, and/or any history or anaphylaxis in reaction to a vaccination
• •Bleeding disorder or history of significant bruising or bleeding following intramuscular (IM) injections or blood draws
• •Immunosuppression anticipated at time of study treatment
• •Patient has received prior therapy consisting of anti-cytotoxic T lymphocyte-associated antigen (CTLA-4), anti-programmed cell death-1 receptor (PD-1), anti-programmed death ligand-1(PD-L1), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• •History of allogeneic tissue/solid organ transplant
• •Active or history of autoimmune disease or immune deficiency
• •History of other cancer within 2 years
• •Active tuberculosis or recent (\<2 week) clinically significant infection, or evidence of active hepatitis B or hepatitis C or known history of positive test for human immunodeficiency virus (HIV) if CD4+ T-cell count is ≤200 cells/microliter.
• •History of pneumonitis requiring systemic steroids for treatment (with the exception of prior resolved in-field radiation pneumonitis)
• •Myocardial infarction within 3 months or prior to study treatment, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure (New York Heart Association \[NYHA\] Grade 3 and 4)
• •Pregnant, planning to become pregnant, or nursing
• •For Study Treatment Stage
• •Patient is receiving treatment with investigational products and/or other anti-cancer therapies.
• •Known exposure to ChAd within the prior 6 months, plan to receive a ChAd-based vaccine in the next 6 months, and/or any history or anaphylaxis in reaction to a vaccination
• •Immunosuppression from concurrent, recent (≤4 weeks) or anticipated treatment with systemic corticosteroids or other immunosuppressive medications or conditions such as hypogammaglobulinemia, or radiation exposure
• •Patients who have not recovered from prior cancer therapy-induced AEs
• •Any severe concurrent non-cancer disease
• •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 if CD4+ T-cell count is ≤200 cells/microliter
• •History of pneumonitis requiring systemic steroids for treatment
• •Myocardial infarction within 6 months prior to initiating study treatment, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure (NYHA Grade 3 and 4).
• •Pregnant, planning to become pregnant, or nursing