BETHLEHEM, Pa. — Pancreatic cancer is one of the deadliest forms of cancer, but there could soon be better preventive measures. A clinical trial for a vaccine is being launched in the Lehigh Valley.
Lehigh Valley Health Network (LVHN) will be opening the clinical trial for an immunotherapeutic pancreatic cancer vaccine.
The randomized trial will evaluate the drug, ELI-002 7P. The medication “teaches” the immune system to fight pancreatic cancer recurrence by targeting specific genetic mutations that cause cancer cells to grow.
“These kinds of personalized cancer vaccines are in the early innings of a major biological breakthrough, and we’re extremely excited to be a part of it."Dr. Suresh Nair, Physician in Chief, Lehigh Valley Topper Cancer Institute
“Stage 3 pancreatic cancer, despite surgery and six months of chemotherapy, returns within two years in 80% of cases. Our hope is that this vaccine will change that,” said Dr. Suresh Nair, Physician in Chief of Lehigh Valley Topper Cancer Institute.
“These kinds of personalized cancer vaccines are in the early innings of a major biological breakthrough, and we’re extremely excited to be a part of it. This one could determine the future of pancreatic cancer treatment and survival.”
Nair will be the principal investigator for the trial.
“The idea is to reprogram the tumor microenvironment,” he explained, saying with pancreatic cancer, there is a sort of “cocoon” around the tumor that doesn’t allow T cells to penetrate. This has long been a problem.
“The new vaccine accumulates in the draining lymph node and sensitizes the patient’s T cells to the specific KRAS mutation that is present in their pancreatic cancer. This allows the body to mount an immune response against the cancer,” he said. “It’s revolutionary.”
There are specific requirements regarding cell mutations.
“Trial candidates are patients who have one of seven KRAS mutations in their tumor sample,” said Morgan Horton, BSN, RN, Director of Minimal Risk Research with LVHN.
“Additionally, participants must be age 18 or older, and in stage 1, 2 or 3 of carcinoma of the pancreas. They will have had a surgical resection, have completed chemotherapy and have no evidence of disease.”
About the trial
Two-thirds of the patients in the randomized study will receive the vaccine and one-third will receive a placebo. Recruitment of patients has already begun and is targeted to continue until November.
Patients who are still receiving chemotherapy post-surgery can be screened for the trial, allowing them to begin sooner.
According to LVHN, to enter the study, a doctor must refer patients who are interested and eligible. Candidates will undergo a screening, which includes bloodwork, an electrocardiogram and imaging if they have not recently had a computed tomography (CT) scan.
This is Phase 2 of the trials. Phase 1 was conducted through the Memorial Sloan Kettering Cancer Alliance (MSK Cancer Alliance) and City of Hope. Lehigh Valley Topper Cancer Institute is part of the MSK Cancer Alliance and will be one of a dozen sites in the United States where the phase 2 trial will take place.
Phase 1 trial results were published in Nature Medicine in January of this year.
Those interested in participating in the ELI-002 7P clinical trial can call 610-402-9543.
