Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer

Exclusion Criteria

• •history of other malignancy within two years prior to screening, except for prostate cancer (T1c, T2ab with definitive treatment, prostate-specific antigen (PSA) \< 1 ng/ml, and without ongoing hormone suppression) or adequately treated in situ carcinoma of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin
• •cystic form of pancreatic cancer; microcystic disease may be eligible upon discussion with Medical Monitor
• •Common Terminology Criteria for Adverse Events (CTCAE) version 3 grade 2 or greater clinical pancreatitis within 8 weeks prior to dosing with OncoVEX\^GM-CSF
• •other than metastases limited to the liver, imaging evidence of metastatic disease to any other organ or tissue
• •any serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
• •evidence of compromised immune function including but not limited to:
• •* clinically significant absolute lymphocyte count \< Lower Limit of Normal (LLN)
• •* known human immunodeficiency virus (HIV), acute or chronic active hepatitis B, or hepatitis C infection;
• •* concurrently taking HIV antiviral medications (e.g. protease inhibitors, azidothymidine, etc.)
• •received intravenous (IV), intramuscular (IM) or subcutaneous (SC) human gamma globulin within 6 months prior to dosing with OncoVEX\^GM-CSF
• •patients taking immunosuppressive agents (e.g. cyclosporine, tacrolimus, or oral or systemic corticosteroids at a dose of \> 10 mg/day of prednisone or equivalent).
• •pregnancy, lactation or lack of effective contraception in women of child-bearing potential (e.g., not post menopausal for \> 2 years, or had tubal ligation); lack of effective contraception in men if the partner is of child-bearing potential; women must have been practicing an effective contraceptive method for at least three months prior to entry in to the trial (hormonal contraception or intrauterine device in conjunction with a barrier method); men must use a condom or be surgically sterilized
• •patients with active bacterial or viral infections that require treatment with systemic antibiotics or antiviral agents within 2 weeks prior to the first dose of OncoVEX\^GM-CSF); (note: patients with active cold sores or other HSV1 infections must wait until those lesions have crusted over before receiving OncoVEX\^GM-CSF)
• •surgery requiring general or spinal anesthesia within four weeks prior to dosing with OncoVEX\^GM-CSF
• •Treatment with an investigational agent within 4 weeks prior to the first dose of OncoVEX\^GM-CSF
• •serum carbohydrate antigen (CA)19.9 levels \> 3000 U/mL at screening
• •evidence of ascites on screening abdominal computed tomography (CT) scan