Protocol:
AAAQ9966

Phase I Study of Talimogene Laherparepvec Administered Endoscopically for the Treatment of Locally Advanced or Metastatic Pancreas Cancer Refractory to at Least One Chemotherapy Regimen

Are you Eligible? (Inclusion Criteria)

Inclusion Criteria:

  • Must have pathologically confirmed, locally advanced or metastatic PDA deemed surgically unresectable by a surgeon with expertise in pancreatic cancer
  • Disease must be refractory to or intolerant of at least first-line chemotherapy which contains 5-fluorouracil or gemcitabine
  • The primary lesion must be accessible for endoscopic biopsy and injection

Exclusion Criteria:

  • Cystic pancreatic cancer; microcystic disease may be eligible
  • More than 5 liver metastases or one liver metastasis measuring more than 3cm CA19-9 >3000 U/mL
  • Oxygen requirement attributable to pleural effusion or other malignant process
  • Symptomatic ascites or radiographic evidence of more than trace ascites
  • Pancreatitis that is active or within the preceding 3 months.
  • Prior chemotherapy within 14 days
  • Previous treatment with talimogene laherparepvec or any other oncolytic virus
  • Active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis) or requires intermittent or chronic systemic.
  • Acute or chronic active hepatitis B infection, hepatitis C infection, or HIV

Specialty Area(s)

Pancreas