Clinicaltrials.gov identifier:
NCT05111353
Treatment
Vaccine study for people diagnosed with pancreatic cancer
Study Contact Information:
William E. Gillanders, M.D.
314-747-0072
[email protected]
Vaccines for Pancreatic Cancer After Chemotherapy and Prior to Surgery
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, but prior to surgery. The vaccine will incorporate proteins that can trigger an immune response and will be administered along with a drug called poly-ICLC which can also activate immune cells.
What the Study Involves
People in this study 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
People may be eligible if they:
- have pancreatic cancer
- have not yet received treatment for their cancer
- and where chemotherapy is considered appropriate to be administered prior to surgery to remove the cancer.
- agree to have tissue samples available.
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.
People with the following may not be eligible:
- evidence of predominantly neuroendocrine cancer
- known to have 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 functional issue