Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer

Inclusion Criteria

• Histologically or cytologically confirmed pancreatic adenocarcinoma with metastasis
• Must be off their prior cytotoxic regimen a minimum of two weeks but no more than four weeks from initiating trial treatment.

Measurable disease by RECIST 1.1.

Demonstrate adequate organ function

Normal Vitamin D level.

Able to submit an archival tumor specimen (primary or metastatic site). Patients with cytology only that do not have adequate archived tumor specimen available, will require a baseline biopsy.

Exclusion Criteria

• Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 3 weeks of the first dose of trial treatment.
• Hypersensitivity to cabiralizumab, nivolumab, or gemcitabine or any of its excipients.
• Previous malignancies (except non-melanoma skin cancers, and in situ bladder, gastric, colorectal, endometrial, cervical/dysplasia, melanoma, or breast cancers) unless complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
• Evidence of central nervous system (CNS) metastasis
• Participants with active, known, or suspected autoimmune disease.
• Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
• Uncontrolled or significant cardiovascular disease
• Prior organ allograft or allogeneic bone marrow transplantation.
• Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis.
• Evidence of coagulopathy or bleeding diathesis.
• Has received prior therapy with a CSF-1R pathway inhibitors, anti-PD-1, anti-PD-L1, anti PD-L2, anti-CTLA-4.