PANVAC-VF Phase III Study Overview
Study Description
Therion is conducting 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 (investigator�s choice) in patients with metastatic (Stage IV) adenocarcinoma of the pancreas who have failed a gemcitabine-containing chemotherapy regimen.
Study Endpoints
The primary endpoint is overall survival (OS). A log-rank test will be performed to compare OS in the vaccine arm versus the OS in the control arm (best supportive care or palliative chemotherapy).
Secondary endpoints include:
Quality of life parameters;
Change in serum CEA and CA19-9 levels;
Response rate;
Safety.
Site Locations
Click here for a list of study sites
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