Testing a personalized cancer vaccine for advanced pancreatic cancer

Plain-English translation of NCT05916261 on ClinicalTrials.gov ↗ · Source last updated October 2023 · Translation generated July 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new approach to treating advanced pancreatic cancer using a personalized vaccine called mRNA-0217/S001, which is customized based on your individual tumor's genetic makeup. The vaccine is designed to teach your immune system to recognize and attack cancer cells. In the first part of the study, patients receive the vaccine alone; in the second part, patients receive it combined with a medication called Pembrolizumab, which helps boost the immune response.

Standard pancreatic cancer treatments are often not effective enough, and many patients don't respond well to them. This trial is exploring whether a personalized vaccine approach—one tailored to each patient's unique tumor—might offer a better way to activate the body's own immune system to fight the cancer.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced pancreatic cancer (locally advanced, recurrent, or spread to other parts of your body) that has either failed standard treatment or you are not suitable for standard treatment
you are 18 years of age or older
you have a life expectancy of at least 4 months
your overall health and ability to perform daily activities meet study requirements (ECOG score of 0 or 1)
you have adequate blood cell counts and organ function as determined by blood tests
you do not have certain viral infections (CMV, EBV, HIV, HBV, HCV, or syphilis)

You likely don't qualify if…

you have received chemotherapy, immunotherapy, or targeted therapy within the last 4 weeks (or 5 half-lives for some drugs)
you have had major surgery other than a diagnostic biopsy within the last 4 weeks
you have received a previous cancer vaccine, cell therapy, or stem cell/organ transplant
you have brain metastases (cancer spread to the brain) with symptoms, spinal cord compression, or cancer spread to the fluid around the brain and spinal cord
you are pregnant, breastfeeding, or unwilling to use reliable contraception during the study and for 90 days after treatment ends

What participation looks like

First, doctors will remove a sample of your tumor and analyze its genetic profile to design your personalized vaccine. In the dose escalation phase, you will receive injections of the personalized vaccine alone. In the dose expansion phase, new participants will receive the vaccine combined with Pembrolizumab injections. You will have regular visits for treatment, blood tests, and imaging scans to monitor how the cancer responds and check for any side effects. The study will track your health and tumor response over time.

AI-generated summary from trial data · Jul 18, 2026 · Not medical advice

Trial locations(1 site)

China

Ruijin-Hainan Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Qionghai, Hainan