Vaccines for Pancreatic Cancer After Chemotherapy

About the Study

This study is looking at the safety of and the immune system response to a vaccine in people diagnosed with pancreatic cancer that would be administered after chemotherapy. The vaccine will incorporate proteins that can trigger an immune response and will be given along with a drug called poly-ICLC which can also activate immune cells.

What the Study Involves

Eligibility will be decided through a series of steps:

Participants must meet eligibility criteria for their tumor to be tested and the vaccine to be developed.
Participants must receive chemotherapy for at least 4 months before receiving the vaccine.
Participant must have no evidence that their tumor has gotten worse within 4 weeks of completing chemotherapy.
Participants whose disease progresses after enrollment while on chemotherapy and after the vaccine has been made may still be eligible to receive the vaccine.

Participants will be assigned by chance () to one of the two groups:.

Group 1: You will receive the vaccine after completion of chemotherapy and surgery. The vaccine will be administered into the muscle on Days 1, 4, 8, 15, 22, 50, and 78 beginning approximately 1 month after surgery.
Group 2: You will receive the vaccine after completion of chemotherapy but before surgery. The vaccine will be administered into the muscle on Days 1, 4, 8, 15, and 22 during the period of time after chemotherapy but before surgery, and Days 50 and 78 after surgery. Optimal timing to start the vaccine is one week after the completion of chemotherapy.

The study team will monitor you for approximately 2 years and 78 days.

Study Site

Missouri

St. Louis
Washington University School of Medicine

This Study is Open To:

People may be eligible if they:

have pancreatic cancer
have not yet received treatment for their cancer
are eligible for chemotherapy
have tissue samples available for testing to see if they are eligible
have an expected life expectancy of at least 12 months

Prior to vaccination, the person needs to have completed at least 4 months of chemotherapy and show no evidence of disease progression within four weeks of last dose of chemotherapy.

This Study is Not Open To:

People with the following may not be eligible:

their pancreatic cancer is a neuroendocrine tumor
have a history of severe reactions to vaccines

People with other medical conditions may not be eligible, including

pregnant and/or breastfeeding
prior cancer diagnosis within 3 years
active autoimmune disease under treatment such as inflammatory bowel disease, ulcerative colitis, Crohn's disease, psoriasis, multiple sclerosis and rheumatoid arthritis
hepatitis B or C
HIV positive
significant blood, lung, heart or kidney function issues