A Phase III Randomized, Controlled Study to Evaluate the Safety and Efficacy of PANVAC™-VF in Combination With GM-CSF Versus Best Supportive Care or Palliative Chemotherapy in Patients With Metastatic (Stage IV) Adenocarcinoma of the Pancreas Who Have Failed a Gemcitabine-Containing Chemotherapy Regimen

Trial Information

A Phase III Randomized, Controlled Study to Evaluate the Safety and Efficacy of PANVAC™-VF in Combination With GM-CSF Versus Best Supportive Care or Palliative Chemotherapy in Patients With Metastatic (Stage IV) Adenocarcinoma of the Pancreas Who Have Failed a Gemcitabine-Containing Chemotherapy Regimen

PANVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the
body can be taught to fight cancer by directing the immune system to attack specific targets
found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This
trial will help determine if this vaccine can help fight cancer.

All patients will be required to sign an informed consent prior to the performance of any
study-related procedures. Patients will be screened for eligibility within 14 days prior to
their anticipated treatment start date (Day 0). Patients who meet all inclusion and
exclusion criteria will be centrally randomized into the study and will receive a unique
patient identification number and a treatment assignment. The ratio of active treatment to
control is 1:1 (PANVAC-VF: best supportive care or palliative chemotherapy).