Personalized mRNA melanoma vaccine: Phase 3 INTerpath-001

Sutter Health reported new results from the international Phase 3 INTerpath-001 trial of a personalized mRNA vaccine for melanoma, according to a feature story published on EurekAlert on 5 November 2026. The authors state that the vaccine combined with pembrolizumab reduced the risk of melanoma recurrence or death at two years compared with pembrolizumab alone eurekalert.org. The release does not give numerical effect sizes for the Phase 3 trial.

The vaccine is experimental and has not been approved by the U.S. Food and Drug Administration eurekalert.org. According to Sutter, its goal is not to guarantee that cancer will be prevented, but to reduce the risk of melanoma returning or spreading after surgery.

How the personalized vaccine works

The vaccine uses mRNA technology to help the immune system recognize and attack cancer cells. Each dose is personalized: the unique genetic characteristics of an individual patient's tumor are used to identify tumor-specific targets eurekalert.org. The patients in question had their melanoma surgically removed.

"What makes this approach so exciting is that we're using the unique characteristics of a patient's cancer to help their immune system recognize it," said Dr. Kevin Kim, oncologist and chief of precision medicine at Sutter Health.

From Phase 2 to Phase 3

Sutter investigators, led by Dr. Kim and Dr. Mohammed Kashani-Sabet, medical director of Sutter CPMC's Cancer Center, took part in the earlier Phase 2 study KEYNOTE-942. It compared the personalized vaccine with pembrolizumab against pembrolizumab alone in patients after surgical removal of melanoma eurekalert.org.

After five years of follow-up in that Phase 2b study, patients who received the vaccine and pembrolizumab had a 49% lower risk of recurrence or death and a 59% lower risk of distant spread or death than those who received pembrolizumab alone eurekalert.org. Sutter notes that these figures differ from the Phase 3 findings because the studies involved different patient populations and follow-up periods.

"Seeing this research progress from an early clinical trial to promising results in a much larger study is encouraging," said Dr. Kashani-Sabet.

If the vaccine is approved, it could offer certain patients with high-risk melanoma another way to reduce the risk of their cancer returning after surgery, the release says eurekalert.org.

Sutter Health: Phase 3 of personalized mRNA melanoma vaccine with pembrolizumab shows lower recurrence risk

How the personalized vaccine works

From Phase 2 to Phase 3

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