A Vaccine (PGV001) in Combination with Immunotherapy (CDX-301 and Poly-ICLC) for the Treatment of Prostate Cancer

Inclusion Criteria

• The subject must have a histologically proven diagnosis of adenocarcinoma of prostate
• The subject should have any one of: * Prostate-specific antigen (PSA) persistence post surgery (defined as a PSA value that fails to become undetectable) by six weeks post treatment * Biochemical recurrence (defined as a PSA value >= 0.2 ng/ml, followed by a subsequent confirmatory PSA value ≥ 0.2 ng/ml ) * An elevated PSA with a doubling time of > 3 months * Or an elevated risk of disease recurrence within 5 years as assessed by decipher™ report (decipher score of ≥ 0.3)
• At the time of treatment, the subjects must have completed radical prostatectomy (rp), all additional standard of care (s.o.c) therapies and be clinically tumor free as defined by s.o.c imaging studies
• Written informed consent obtained prior to any study procedure
• The subject must be able to provide the necessary tissue sample for sequencing, either by surgical resection or open-surgical or core biopsy sampling of the primary tumor
• This requirement may be satisfied by providing an archival tissue sample that has been stored in ribonucleic acid (RNA) later, flash-frozen, or under other RNA/deoxyribonucleic acid (DNA) preserving conditions from an earlier resection
• This requirement may also be satisfied by providing RNA/DNA sequencing from a Clinical Laboratory Improvement Act (CLIA) certified genomic sequencing laboratory
• Before administration of the investigational product, the following time must have elapsed: * At least (4) weeks post general anesthesia * At least seventy-two (72) hours post local/epidural anesthesia * The subject must complete all prior systemic chemotherapy therapy, and all adverse events have either returned to baseline or have stabilized at least four (4) weeks prior to administration of the investigational product * The subject must complete all prior systemic radiation therapy at least four (4) weeks prior to administration of the investigational product. The subject must not have received a radiopharmaceutical within eight (8) weeks prior to the administration of the investigational product * The subject may continue hormonal therapy (e.g. anti-androgens) during the study * Subjects may have a detectable or rising PSA provided there is no radiographic evidence of metastatic disease. For patients with a rising PSA, the doubling time should be > 3 months
• The subject must have a life expectancy greater than twelve (12) months at the time of screening as assessed by the treating physician
• The subject must have a performance status of 0-1 as determined by criteria set forward by the Eastern Cooperative Oncology Group
• Absolute neutrophil count >= 1.0 x 10E3/ml
• Platelet count >= 50 x 10E3/uL
• Creatinine < 2.5 mg/dl
• Total bilirubin =< 1.5 mg/dl, (except in patients with gilbert syndrome who can have total bilirubin < 3.0 mg/dl)
• Transaminases < 2 times above the upper limits of the institutional normal
• International normalized ratio (INR) < 2 if off of anticoagulation. Patients on anticoagulation therapy with an INR > 2 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage
• Adequate venous access (for leukapheresis and blood draws)
• The subject must be male 18 years of age or older
• The subject must be deemed competent to give informed consent
• The subject must agree to use a condom and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant

Exclusion Criteria

• The subject has metastatic disease at the time of treatment
• Patients with history of acute myeloid leukemia (AML) or tumors with known Flt3 mutations/amplifications
• The subject has a history of unrelated neoplastic disease, which has been deemed active within thirty-six (36) months of the screening evaluation, with the exception of the following: * Non-invasive non-melanoma skin cancer such as superficial basal cell carcinoma or squamous cell carcinoma * Patients with other completely resected malignancies in the prior three years and no evidence of disease will be evaluated on a case-by-case basis with eligibility determined based on discussion with the principal investigator
• The subject has a prior history of unrelated neoplastic disease and has received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation
• The subject has a history of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), chronic active hepatitis B or hepatitis C with positive polymerase chain reaction (PCR)
• The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression; or the subject is currently receiving any drug or supplement which is known to be associated with systemic immune suppression including those drugs which are prescribed for solid organ or stem cell transplant, autoimmune/inflammatory disorders, or other related medical conditions
• The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a systemic autoimmune/inflammatory disease or other autoimmune disorder with the exception of: * Vitiligo * Hypothyroidism
• The subject has a history of anaphylaxis or other serious adverse reactions relating to administration of any components of the investigational product
• The subject has a history of serious allergic reaction to any substance, resulting in hospitalization or requiring other emergent medical attention
• The subject has a history of advanced cardiac, hepatic or renal disease or other chronic illness
• The subject has been diagnosed and treated at an external facility, and the resulting tissue specimen is of insufficient quality such that it precludes clinical sequencing or any other necessary study procedure, and the subject is unwilling to undergo an additional biopsy procedure
• Previous treatment with therapeutic cancer vaccine of any type
• The subject is less than eighteen (18) years of age, or otherwise unable to give informed consent due to minor status
• The subject is a prisoner, as defined by (45 Code of Federal Regulations [CFR] 46.303[c])
• The subject is cognitively impaired, and unable to give informed consent