RO7009789 with or without Nab-paclitaxel and Gemcitabine Hydrochloride before and after Surgery in Treating Patients with Newly Diagnosed Pancreatic Cancer That Can Be Removed by Surgery

Inclusion Criteria

• Histological documentation of primary adenocarcinoma of the pancreas
• Surgically eligible for tumor resection with curative intent
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Absolute neutrophil count (ANC) >= 1,500
• Hemoglobin (Hgb) > 9
• Platelets (Plt) > 100
• Creatinine (Cr) < 1.5 upper limit of normal (ULN)
• Total bilirubin =< 1.5 x ULN
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN (values post biliary stenting allowed for eligibility)
• Signed, written informed consent

Exclusion Criteria

• Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms; in addition, adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded
• Patients with M1 disease or a history of M1 disease
• Patients with any type of recurrent pancreatic adenocarcinoma
• Prior therapy such as chemotherapy or radiation therapy or anti-tumor experimental therapy for pancreatic cancer
• Previous treatment with any other compound that targets CD40
• Concurrent treatment with any anticancer agent outside of this protocol
• Prior allogeneic bone marrow transplant
• History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen’s syndrome, vasculitis/arteritis, Behcet’s syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis; (vitiligo is allowed)
• History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, hospitalization for acutely decompensated congestive heart failure
• History of deep venous thrombosis or migratory thrombophlebitis (Trousseau)
• Hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrand disease, or cancer associated disseminated intravascular coagulation [DIC])
• Prior allergic reactions attributed to other monoclonal antibodies
• Concurrent or planned concurrent treatment with systemic high dose (immunosuppressive) corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline
• Treatment on another therapeutic clinical trial within 4 weeks of enrollment in this trial
• Concurrent or planned concurrent treatment with anticoagulants such as Coumadin or heparin, except to maintain patency of in dwelling catheters
• Ongoing or active infection; treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed)
• Pregnancy or breast-feeding – female patients must be surgically sterile, be post-menopausal, or must agree to use effective contraception during the period of therapy and for 90 days following the last dose of RO7009789; all female patients with reproductive potential must have a negative pregnancy test prior to enrollment; women or men of reproductive potential may not participate unless they agree to use an effective contraceptive method; female patients should not become pregnant while participating in this research study or for 90 days following therapy; male patients should not father a child while in this research study or for 90 days following therapy
• Other uncontrolled, concurrent illness that would preclude study participation; or, psychiatric illness or social challenges that would entail unreasonable risk or preclude informed consent or compliance with study procedures