Comparing Two Vaccine Treatments With Immunotherapy for Pancreatic Cancer Before and After Surgery

About the Study

This study is evaluating two approaches designed to help the immune system recognize and attack pancreatic cancer:

• A KRAS-targeted vaccine, which focuses on a common mutation found in pancreatic cancer
• A whole-cell vaccine (GVAX), which trains the immune system to recognize multiple features of cancer cells

All participants will receive a combination of treatments before and after surgery, including:

• A study vaccine (one of the two options above)
• Chemotherapy (cyclophosphamide)
• Two immunotherapy drugs (balstilimab and AGEN2373)

These treatments are designed to work together to strengthen the immune response to cancer.

What the Study Involves

If you join this study:

• You will be assigned to one of two treatment groups.
• You will receive study treatment before surgery to remove your cancer.
• You will continue treatment after surgery.

During the study, participants will:

• Have regular clinic visits for treatment and monitoring
• Undergo blood tests and physical exams
• Have imaging scans to monitor their cancer
• Be followed for up to 2 years after treatment

People are assigned to one of two treatment arms in this study, with 6 treatment cycles total.

Cycle 1 will be before surgery, and Cycle 2 will be after surgery, both 14 days long. Cycles 3-6 will be 28 days long each.

• Treatment Group 1:
  • GVAX (vaccine): Given as an injection on day 2 of each cycle for 6 cycles total
  • Balstilimab (immunotherapy): Given as an IV infusion on day 1 of each cycle
  • Cyclophosphamide (chemotherapy): Given as an IV infusion on day 1 of each cycle
  • AGEN2373 (immunotherapy): Given as an IV infusion on day 1 of each cycle
• Treatment Group 2:
  • mKRASvax (vaccine): Given as an injection on day 1 of each cycle as well as Day 8 of cycle 1 only
  • Balstilimab (immunotherapy): Given as an IV infusion on day 1 of each cycle
  • Cyclophosphamide (chemotherapy): Given as an IV infusion on day 1 of each cycle
  • AGEN2373 (immunotherapy): Given as an IV infusion on day 1 of each cycle

People who are 18 years and older, who meet the following criteria:

• Have pancreatic cancer that meets the following criteria:
  • Newly diagnosed
  • Biopsy-proven adenocarcinoma of the pancreas
  • Tumor can be removed surgically
• Have not yet received treatment for their pancreatic cancer
• Are healthy enough to participate based on lab tests and overall condition
• Willing to attend study visits, undergo required surgical resection, treatments and testing
• For women, be non-pregnant and use contraceptives for the study duration
• For men, use contraceptives for the study duration

People who:

• Have already received any pancreatic cancer treatment (such as radiation, chemotherapy, etc)
• Have received immunotherapy for previous cancer treatment
• Pancreatic cancer is not surgically removable
• Have an active autoimmune condition or require medications that weaken the immune system
• Have active infections such as HIV, Hepatitis B or Hepatitis C
• Have had major surgery or a live vaccine within 28 days of study treatment
• Have certain complications, such as fluid buildup (ascites/pleural effusion) or lung issues
• Are pregnant or breastfeeding
• Prior organ or stem cell transplantation
• Have a hypersensitivity to any monoclonal antibody
• Already enrolled in another therapeutic clinical study