Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Inclusion criteria

• Age ≥18 years of age .
• Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
• Capable of providing informed consent and complying with Trial procedures.
• Karnofsky Performance Status (KPS) of ≥ 70%.
• Life expectancy ≥ 12 weeks.
• Measurable tumor lesions according to RECIST 1.1 criteria.
• Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.

Exclusion criteria

• Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU (5-Fluorouracil) or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
• Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
• Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
• Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
• History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.
• Laboratory values: Screening serum creatinine > upper limit of normal (ULN); total bilirubin > (ULN); alanine aminotransferase (ALT) and Aspartate transaminase (AST) ≥ 2.5 ULN or ≥ 5.0×ULN if liver metastases are present; absolute neutrophil count <1,500/mm3, platelet concentration <100,000/mm3, hematocrit level <27% for females or <30% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) >1.5×ULN unless on therapeutic doses of warfarin.
• Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
• History of HIV infection or active or chronic hepatitis B or C.
• Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
• Major surgery within 4 weeks prior to initiation of study treatment.
• Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.
• Any condition that is unstable and could jeopardize the patient's participation in the study.
• Patient has a transplanted organ.
• Patients with a history of autoimmune disease.
• Prior Programmed cell death protein-1 (PD-1) or Programmed death-ligand-1 (PD-L1) therapy.
• Patients taking any chemo or immunosuppressive steroids (equivalent to > 20 mg hydrocortisone per day).
• Patients cannot have > Grade 1 pre-existing peripheral neuropathy (per CTCAE).