QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy

Treatment will be administered in two phases. Subjects will continue treatment until they
experience progressive disease (PD) or experience unacceptable toxicity (not correctable with
dose reduction), withdraw consent, or the investigator feels it is no longer in the subject's
best interest to continue treatment. Those who have a complete response (CR) will enter phase
2 of the study. Subjects may remain on phase 2 of the study for up to 1 year. Treatment will
continue throughout phase 2 until the subject experiences PD or unacceptable toxicity,
withdraws consent, or the investigator feels it is no longer in the subject's best interest
to continue treatment.

Inclusion Criteria:

- Age ≥ 18 years old.

- Able to understand and provide a signed informed consent that fulfills the relevant
IRB or IEC guidelines.

- Histologically-confirmed pancreatic cancer with progression on or after SoC therapy.

- ECOG performance status of 0 to 2.

- Have at least 1 measurable lesion and/or non-measurable disease evaluable according to
RECIST Version 1.1.

- Must have a recent tumor biopsy specimen following the conclusion of the most recent
anti-cancer treatment. If a historic specimen is not available, the subject must be
willing to undergo a biopsy during the screening period.

- Must be willing to provide blood samples for exploratory analyses.

- Ability to attend required study visits and return for adequate follow-up, as required
by this protocol.

- Agreement to practice effective contraception for female subjects with child-bearing
potential and non-sterile males.

Exclusion Criteria:

- History of persistent grade 2 or higher (CTCAE Version 4.03) hematological toxicity
resulting from previous therapy.

- History of other active malignancies or brain metastasis except: controlled basal cell
carcinoma; prior history of in situ cancer (eg, breast, melanoma, cervical); prior
history of prostate cancer that is not under active systemic treatment (except
hormonal therapy) and with undetectable prostate-specific antigen (PSA) (< 0.2 ng/mL);
bulky (≥ 1.5 cm) disease with metastasis in the central hilar area of the chest and
involving the pulmonary vasculature. Subjects with a history of another malignancy
must have > 5 years without evidence of disease.

- Serious uncontrolled concomitant disease that would contraindicate the use of the
investigational drug used in this study or that would put the subject at high risk for
treatment-related complications.

- Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's
disease, autoimmune disease associated with lymphoma).

- History of organ transplant requiring immunosuppression.

- History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative
colitis).

- Requires whole blood transfusion to meet eligibility criteria.

- Inadequate organ function, evidenced by the following laboratory results:

- White blood cell (WBC) count < 3,500 cells/mm3

- Absolute neutrophil count < 1,500 cells/mm3.

- Platelet count < 100,000 cells/mm3.

- Hemoglobin < 9 g/dL.

- Total bilirubin greater than the upper limit of normal (ULN; unless the subject
has documented Gilbert's syndrome).

- Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT])
> 2.5 × ULN (> 5 × ULN in subjects with liver metastases).

- Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver
metastases, or >10 × ULN in subjects with bone metastases).

- Serum creatinine > 2.0 mg/dL or 177 μmol/L.

- International normalized ratio (INR) or activated partial thromboplastin time
(aPTT) or partial thromboplastin time (PTT) >1.5 × ULN (unless on therapeutic
anti-coagulation).

- Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or
clinically significant (ie, active) cardiovascular disease, cerebrovascular
accident/stroke, or myocardial infarction within 6 months prior to first study
medication; unstable angina; congestive heart failure of New York Heart Association
grade 2 or higher; or serious cardiac arrhythmia requiring medication.

- Dyspnea at rest due to complications of advanced malignancy or other disease requiring
continuous oxygen therapy.

- Positive results of screening test for human immunodeficiency virus (HIV), hepatitis B
virus (HBV), or hepatitis C virus (HCV).

- Current chronic daily treatment (continuous for > 3 months) with systemic
corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone),
excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic
reaction or anaphylaxis in subjects who have known contrast allergies is allowed.

- Known hypersensitivity to any component of the study medication(s).

- Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug
reaction with any of the study medications. See Excluded Medications list.

- Participation in an investigational drug study or history of receiving any
investigational treatment within 14 days prior to screening for this study, except for
testosterone-lowering therapy in men with prostate cancer.

- Assessed by the investigator to be unable or unwilling to comply with the requirements
of the protocol.

- Concurrent participation in any interventional clinical trial.

- Pregnant and nursing women.