mRNA Vaccine + Immunotherapy for Melanoma

This trial tests whether adding a new mRNA vaccine (mRNA-4157) to the standard immunotherapy drug pembrolizumab (also known as KEYTRUDA) can help people with melanoma remain cancer-free longer. It targets individuals who have undergone surgery to remove melanoma that spread to their lymph nodes and are at high risk of recurrence. Participants should be cancer-free post-surgery and show no signs of brain metastases or other active cancers. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic steroid therapy or any other immunosuppressive therapy within 7 days before starting the trial.

Research has shown that the combination of mRNA-4157 and pembrolizumab has been tested for safety in people with melanoma. In these studies, participants generally tolerated the treatment well. Most side effects were mild or moderate, with only about 25% experiencing severe side effects. Importantly, the combination did not increase immune-related side effects beyond the usual levels seen with these treatments. This safety data suggests that the treatment is reasonably safe, but discussing potential risks with a healthcare provider remains important.¹²³⁴⁵

Researchers are excited about the combination of mRNA-4157 and pembrolizumab for melanoma because it represents a novel approach to treatment. Unlike traditional therapies, which often focus on directly attacking cancer cells, mRNA-4157 is a personalized cancer vaccine that works by stimulating the immune system to recognize and fight melanoma more effectively. This approach is combined with pembrolizumab, an immunotherapy that has already shown promise in enhancing the body's immune response against cancer. The potential for a tailored vaccine to work alongside an established immunotherapy offers hope for more precise and effective treatment options for melanoma patients.

Research has shown that using mRNA-4157 with pembrolizumab, which participants in this trial may receive, may help treat melanoma. Studies found that this combination reduced the risk of cancer returning or causing death by 49%. It also decreased the chance of cancer spreading or causing death by 62% compared to using pembrolizumab alone, another treatment arm in this trial. This suggests that mRNA-4157, when used with pembrolizumab, could be more effective at preventing melanoma from returning after surgery.¹²³⁵⁶