Personalized Therapeutic Anti-tumor Vaccine and Pembrolizumab in Treating Patients with Stage IV Non-small Cell Lung Cancer

Inclusion Criteria

• Histologically confirmed stage IV NSCLC (squamous, adenocarcinoma, or large cell carcinoma) that is stable or has partially responded after four cycles of a platinum doublet; (a complete response is not allowed) there is no restriction on prior lines of therapy; maintenance chemotherapy is not allowed
• Sufficient tumor tissue must be available for histologic assessment of PD-L1 expression and whole exome sequencing
• Measurable disease by RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1
• Absolute neutrophil count >= 1,500/mcl
• Platelets >= 100,000/mcl
• Hemoglobin >= 9.0 g/dL
• Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR direct bilirubin =< IULN for patients with total bilirubin > 1.5 x IULN
• Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) =< 2.5 x IULN (or =< 5 x IULN for patients with liver metastases)
• Albumin >= 2.5 mg/dL
• Serum creatinine =< 1.5 x IULN OR creatinine clearance by Cockcroft-Gault >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x IULN
• International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
• Activated partial thromboplastin time (aPTT) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
• Sexually active women of childbearing potential and men must agree to use 2 methods of contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 120 days after last dose of pembrolizumab; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
• Ability to understand and willingness to sign an Institutional Review Board (IRB), approved written informed consent document (or that of legally authorized representative, if applicable)

Exclusion Criteria

• Patients with EGFR- or ALK-positive disease are not eligible for this study
• Treatment with an anti-cancer monoclonal antibody within 4 weeks prior to day 1 or has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent; NOTE: subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study; NOTE: if subject received major surgery, s/he must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to day 1
• Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
• Prior treatment with a cancer vaccine
• Prior treatment with an anti-CTLA-4 agent
• Received a live vaccine within 30 days prior to day 1
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to day 1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment
• Known carcinomatous meningitis
• Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to day 1
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in the study
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, underlying pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements
• Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids (prednisone dose of 5 mg or less per day is allowed), or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Known history of, or any evidence of active, non-infectious pneumonitis
• Pregnant and/or breastfeeding; patient must have a negative serum or urine pregnancy test within 72 hours of study entry
• Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
• Known history of active tuberculosis (TB)
• Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)