After a phase 1 trial showed that the ELI-002 vaccine was safe and efficacious in treating stages 1 to 3 resected KRAS-mutant pancreatic cancer, researchers are now expanding their research to a phase 2 trial that is currently being conducted in cancer centers nationwide.
While the first patient has already been dosed in the trial, treatment sites are still recruiting eligible participants for the trial, so interested patients can talk to their providers to see if they would be a good fit, explained Dr. Suresh Nair in an interview with CURE®.
States with cancer centers conducting trials on ELI-002 7P*:
- Arizona
- California
- Colorado
- Florida
- Iowa
- Louisiana
- Massachusetts
- Minnesota
- New York
- Pennsylvania
- Tennessee
- Texas
- Wisconsin
*According to the trial’s listing on ClinicalTrials.gov
Trial of ELI-002 7P Will be in Academic and Community Centers
“It’s a national and international trial scattered in [cancer treatment centers] across the country,” said Nair, who is the physician in chief at the Lehigh Valley Topper Cancer Institute in Salisbury, Pennsylvania.
Nair’s institution is one of the community oncology centers that are running the trial; the majority of cancer treatment centers involved in this trial — and many others — are larger, academic centers. However, Nair mentioned that community sites offer easier accessibility for patients.
“We’re proud to be a community-academic site where there’s easier accessibility for patients of all socioeconomic groups, including minority patients,” Nair said. “It just strengthens randomized trials to have participation by the average patient in the country.”
Nair explained that approximately 15% of cancer care is given at large, specialized cancer centers — the same institutions that conduct the majority of early-phase research.
“Those [study] results are extrapolated to the other 85% and sometimes in the community setting, there are potentially more comorbidities,” Nair explained. “Often, patients of higher education and socioeconomic class get to the larger [National Cancer Institute-designated] cancer centers in the cities. Community patients potentially have more barriers, and other things to deal with, so you want to make sure that the medication you’re testing and approving [works for patients] across the country.”
READ MORE: Pancreatic Cancer Vaccine Offers ‘New Twist’ on Vaccination Technology
Eligibility for the Cancer Vaccine Trial
Regardless of where patients are going to be treated in the ELI-002 7P trial, they must all fit the study criteria. According to the trial’s listing on ClinicalTrial.gov, patients must:
- Have a KRAS- NRAS-mutant solid cancer
- Be free of recurrent disease, per CT scan (provides detailed internal images of the body)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, indicating that they can perform all their daily tasks with little to no help
Patients cannot participate in the trial if they have the presence of tumor mutations that have an approved therapy; known brain metastases (cancer that spreads to the brain); or use drugs that suppress the immune system.
The main goal of the trial is to determine if ELI-002 7P improves 150-week disease-free survival (DFS; time after treatment patients show no signs or symptoms of the disease) compared to the current standard of care. Researchers will also be investigating the DFS rate one year after treatment; the safety of ELI-002; and the objective response rate (ORR; percentage of patients whose disease shrinks or completely disappears) in patients who crossover from the standard-of-care group to the ELI-002 group.
According to the trial’s listing, researchers plan on enrolling 156 patients and expect to complete the study in November 2026.
“We’re hoping that accrual will finish by the holidays, and then over the next one or two years, we’ll get results,” Nair said.
The Future of Cancer Vaccines
Looking ahead, Nair said that successful results from this clinical trial may eventually, “bring a whole fleet of personalized vaccines into the immunotherapy portfolio.”
Additionally, ELI-002 7P is not the only cancer vaccine being investigated. Researchers are currently looking at vaccines for melanoma, brain, breast and other cancers, too.
“It’s hopeful that all of these things are happening fast and furious when cancer research is often at a slow pace,” Nair said. “Most of us have family members who are facing cancer right now … we want to see progress so we can take the next step.”
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