Study Will Test Vaccine That Kills Cancer Cells Without Side Effects

A Phase III clinical trial will test a new cancer vaccine that is designed to harness the power of a person’s immune system instead of eliminating it. This is in contrast to many traditional cancer treatments such as chemotherapy that work by killing off cancer cells but also killing off non-cancerous cells throughout the body, which can cause a range of side effects, including hair loss, nausea, vomiting or knocking out a person’s immune system, putting them at risk of life-threatening infections.

The vaccine is known as a tumor lysate particle only (TLPO) vaccine that uses a person’s tumor cells to identify particular parts that are then presented back into the body using the vaccine in a way that can stimulate the immune system to gain the ability to detect these cancer cells like an infection, allowing the immune system to fight the cancer itself.

In Phase II clinical trials, the TLPO cancer vaccine was tested in hundreds of patients with advanced forms of melanoma. Data from those trials showed nearly 95 percent of people given only the vaccine were still alive three years after starting treatment and 64 percent were still disease-free. Among the most advanced forms of melanoma, disease-free survival after three years for people with stage III disease was 60 percent in the vaccine-only group, compared to about 39 percent in the placebo group. Disease-free survival for those with stage IV disease was about 68 percent in the vaccine-only group and zero in the placebo group. The most common side effects were redness or pain at the injection site, fever and fatigue after the injection — similar to other vaccines that stimulate an immune response.

However, Vernon Sondak, MD, cutaneous oncologist at Moffit Cancer Center who was not involved in the clinical trial but has worked with tumor lysate vaccines throughout his career, said that even though these results are promising, the Phase II clinical trials aren’t conclusive. The new larger Phase III clinical trial will have to ultimately validate if this cancer vaccine will truly be a game-changer in the field.