A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Micoenvironment in Resectable Pancreatic Cancer

Inclusion Criteria:

- Previously untreated, apparently resectable adenocarcinoma of the pancreas at
registration.

- Age greater than or equal to 18 years

- ECOG performance status of 0-2.

- Standard laboratory criteria for hematologic, biochemical, and urinary indices within
a range that, in the opinion of the physician, clinically supports enrollment of the
subject on the trial.

a. Note: subjects must have: Creatinine < 2xULN, Neutrophils >1.5x109/L, total
bilirubin < 3xULN, AST <5xULN, ALT <5xULN, and Platelets >100,000/mm3

- Ability to provide written informed consent

Exclusion Criteria:

- Subjects with hypercalcemia (blood levels greater than 11.5 mg/dL). In subjects
creatinine clearance <60mL/min, blood calcium levels must be 9.5 mg/dL or lower.

- Subjects who are currently pregnant, planning to become pregnant, or breast-feeding

1. Females participants of child-bearing potential are required to use an effective
contraception method (see Appendix A) or abstain from intercourse during
treatment and for at least 5 months following the last dose

2. Males participants with partners of child-bearing potential are required to use
an effective contraception method (see Appendix A) or abstain from intercourse
during treatment and for at least 5 months following the last dose 3. Subjects
who, in the opinion of the physician, would not be clinically appropriate for
receipt of the therapy regimen associated with participation 4. Subjects with
contraindications to immune checkpoint therapy, as follows:

1. Interstitial lung disease that is symptomatic or may interfere with the detection
and management of suspected drug-related pulmonary toxicity

2. Prior organ allograft or allogeneic bone marrow transplantation

3. Pre-existing thyroid abnormality with thyroid function that cannot be maintained
in the normal range with medication

4. Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma,
atopic dermatitis, or endocrinopathies manageable by hormone replacement; other
autoimmune conditions may be allowable at the discretion of the principal
investigator

5. Condition requiring systemic treatment with either corticosteroids

- Systemic steroids at physiologic doses (equivalent to dose of oral
prednisone 10 mg) are permitted. Steroids as anti-emetics for chemotherapy
are strongly discouraged (see section 5.1.3)

- Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids
with minimal systemic absorption are permitted