Study of IDO Inhibitor in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer

Inclusion Criteria:

   - Patient has definitive histologically or cytologically confirmed metastatic
   adenocarcinoma of the pancreas. Patients with islet cell or neuroendocrine neoplasms
   are excluded.

   - Initial diagnosis of metastatic disease must have occurred ≤8 weeks prior to entry in
   the study.

   - Patient has one or more metastatic tumors measurable per RECIST 1.1 by CT scan ≤4
   weeks prior to entry into the study

   - Male or non-pregnant and non-lactating female, and ≥18 years of age.

   - Patients must have received no previous radiotherapy, surgery, chemotherapy or
   investigational therapy for the treatment of metastatic disease.

   - Prior treatment with gemcitabine and/or nab-paclitaxel in the adjuvant setting is
   allowed, provided at least 6 months have elapsed since completion of the last dose and
   no lingering toxicities are present.

   - Patients cannot have received any other immunomodulatory therapies (including
   vaccines) as treatment for this or any other cancer.

   - Patient has a Karnofsky performance status (KPS) ≥ 70.

   - Patients should be asymptomatic for jaundice prior to Day 1.

Exclusion Criteria:

   - Patients may not be receiving (or received prior to enrollment) any other
   investigational agents for metastatic disease.

   - Patient has known brain metastases,

   - Patient has only locally advanced disease.

   - Lymph node only metastases even if considered M1 disease by official staging criteria.

   - History of malignancy in the last 3 years. Patients with prior history of in situ
   cancer or basal or squamous cell skin cancer are eligible. Patients with other
   malignancies are eligible if they were cured by surgery alone or surgery plus
   radiotherapy and have been continuously disease-free for at least 3 years.

   - Patients with any active autoimmune disease

   - Patient has undergone major surgery, other than diagnostic surgery (ie, surgery done
   to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to
   Day 1 of treatment in this study.