Vaccine for those at High Risk of Developing Pancreatic Cancer

About the Study: 

This study is testing an experimental vaccine that helps the immune system recognize changes in a protein called KRAS, which is commonly involved in pancreatic cancer. The vaccine is given with an immune-boosting medicine that helps improve the body’s response.

The main goals are to see whether the vaccine is safe and whether it triggers an immune response that could protect against pancreatic cancer.

There are two groups in the study:

• Study Group A: People at high inherited risk for pancreatic cancer based on family history or genetic mutations.
• Study Group B: People with pancreatic cysts that carry KRAS mutations and are being evaluated for removal.

All participants will also be offered annual follow-up visits after the initial treatment period to support long-term monitoring.

What the Study Involves: 

If a person enrolls in the study, here’s what they can expect:

Group A:

• Receive the KRAS vaccine with the immune-boosting medication called poly-ICLC at weeks 1, 3, and 5.
• Receive a booster dose at week 13.
• Return for a clinic visit about 4 weeks after the last vaccine for safety evaluation and treatment completion checks.

Group B:

• Receive the KRAS vaccine with the immune-boosting medication called poly-ICLC at weeks 1 and 2.
• Return for a safety check during week 4 (before planned cyst surgery) and an end-of-treatment visit during week 8.

All participants may stay in the study after the initial treatment phase and have annual follow-up visits to monitor immune response, health status, and any signs of pancreatic changes. Visits may include blood tests and other assessments.

This study is open to people who are at increased risk for pancreatic cancer, including:

• Adults (18 years and older) with certain family histories of pancreatic cancer, especially multiple affected relatives.
• People with inherited gene mutations such as ATM, BRCA1, BRCA2, CDKN2A, MLH1, MSH2, PMS1, MSH6, EPCAM or PALB2 that raise their lifetime pancreatic cancer risk.
• People with pancreatic cysts that have specific KRAS mutations identified by testing.
• People who are healthy enough to participate in vaccine administration and follow-up visits.

This study is not open to people who:

• Need another form of cancer treatment while on this study.
• Have an active immunodeficiency condition such as HIV or Hepatitis B or C.
• Have a serious uncontrolled illness (like advanced infection, heart failure, metastatic cancer, or uncontrolled psychiatric conditions) that would interfere with study participation.
• Do not meet other health and risk criteria required by the study protocol.