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)
- 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
- 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