Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Metastatic, Pancreas, Adenocarcinoma Read More

Inclusion Criteria:

• cytological or histological proof of adenocarcinoma of the pancreas
• unresectable, locally advanced disease (isolated liver metastases are permitted)
• tumors of at least 1 cm diameter at screening
• measurable disease using Response Evaluation Criteria In Solid Tumors (RECIST) criteria

• failure of either standard therapy, OR any one of the following:

  • no alternative therapeutic of higher curative potential is available;
  • investigator determination that patient could not tolerate alternative therapeutic due to unacceptable toxicity; or,
  • patient refusal to be treated with available alternative therapeutic
• age > 18 years
• life expectancy > 3 months

• adequate bone marrow function as indicated by:

  • White blood cells (WBC) ≥ 3.0 x 10^9/L
  • platelets ≥ 100 x 10^9/L
  • hemoglobin ≥ 8.5 gm/dL

• adequate liver function as indicated by:

  • bilirubin < 1.5 x upper limit of normal (ULN)
  • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 x ULN in case of presence of liver metastasis
  • ALT or AST < 2.5 x ULN in case of absence of liver metastasis
• adequate renal function as indicated by a serum creatinine level < 1.5 x ULN.
• adequate hemostasis indicated by international normalized ratio (INR) ≤ 1.5
• mentally, physically and geographically able to undergo treatment and follow-up
• provided written informed consent
• first patient in each cohort only: seropositive for herpes simplex virus type 1 (HSV1)

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