Evaluating a cancer vaccine as post-surgery therapy for patients with advanced melanoma

The aim of this study was to evaluate the safety and effectiveness of a cancer vaccine for patients with advanced melanoma. The study found that the vaccine was safe and increased patient survival without worsening of the disease.

Treatment for early-stage melanoma includes surgery to remove the tumor. For more advanced melanoma, some patients need add-on therapy following surgery to ensure all the cancer cells are killed. Add-on therapy options can include immunotherapy (IT). IT activates the patient’s immune system to locate and kill the cancer cells.

For some patients, IT fails to activate their immune system. Vaccines can be given to give the immune system an activating boost. The TLPLDC (tumor lysate, particle loaded, dendritic cell) vaccine is created using inactive versions of the patient’s tumor. When the immune system meets the vaccine, it knows the characteristics of the tumor that needs to be targeted and killed. It is not yet clear if the TLPLDC cancer vaccine can improve a patient’s response to IT.

This study included 144 patients with advanced melanoma. All patients underwent surgery to remove the tumor. 103 patients then received the TLPLDC vaccine. 41 patients were given a placebo. Patients were followed up for an average of 19.1 months.

In patients who completed all treatment doses, more patients in the vaccine group were alive disease-free (62.9%) compared to the placebo group (34.8%) after 2 years and after 3 years (55.9% vs 27.9%). In patients who did not complete the full treatment, there was no significant difference between groups.

35.9% in the vaccine group and 31.7% in the placebo group experienced side effects. Most of these side effects were minor. They included fatigue, headache, diarrhea, cough, and reddening or irritation of the skin. 

The study concluded that the vaccine was safe and improved the outcome of patients with advanced melanoma who completed therapy.

The follow-up time was short. There was not an equal number of patients in each group with each stage of melanoma. This trial was funded by Elios Therapeutics, the manufacturer of the vaccine.