A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute«-Pancreas (algenpantucel-L) immunotherapy in Subjects with Surgically Resected Pancreatic Cancer.

Objective

This study plans to learn more about an investigational immunotherapy drug called HyperAcute«-Pancreas immunotherapy given in combination with chemotherapy and chemoradiation to compare the effects, good and/or bad, of standard of care therapy (gemcitabine chemotherapy alone or with chemoradiation) with or without the addition of the study immunotherapy drug to find out which treatment is better. The study drug is administered through injection.

IRB Protocol Number

10-0314

Principal Investigator(s)

COLIN WEEKES

Cancer Trials

• Digestive System Cancer

Sponsor(s)

NewLink Genetics

Contact

KIRSTEN MILLER at 720-848-5278
or KIRSTEN.MILLER@UCDENVER.EDU

Eligibility and Other Participant Information

What To Expect : Once eligibility has been established through a screening period, you will receive these injections throughout your chemotherapy and chemoradiation schedule for up to a total of 12 immunizations, as long as your tumor does not grow and as long as you do not show any serious side effects from the immunizations. The duration for chemotherapy (with or without radiotherapy and/or immunotherapy) is about 6-8 months and follow up will include follow up visits every 3 months for 3 years after treatment and then every 6 months for the next 2 years. // Eligibility criteria include but are not limited to: Patients 18 years or older with Surgically Resected Pancreatic Cancer.