Study of AM0010 With FOLFOX Compared to FOLFOX Alone Second-line Tx in Pts With Metastatic Pancreatic Cancer

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Criteria
Inclusion Criteria:

The presence of metastatic pancreatic adenocarcinoma
Measurable disease per RECIST v.1.1
Patient must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
Eastern Cooperative Oncology Group Performance Status of 0 - 1
Patient must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
Patients must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
No peripheral neuropathy
No known history of dihydropyrimidine dehydrogenase deficiency
Exclusion Criteria:

Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
Patient has received prior treatment with AM0010 or fluoropyrimidine/platinum containing regimen
Patients who were intolerant of a gemcitabine containing regimen.
History of positivity for human immunodeficiency virus
Chronic active or active viral hepatitis A, B, or C infection
Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
Pregnant or lactating women
Patients with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
Clinically significant ascites defined as requiring ? 1 paracentesis every 2- weeks
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1