Cutaneous melanoma is a type of skin cancer. It is the most aggressive and life-threatening form of skin cancer, and can appear anywhere on the body. Locally advanced cutaneous melanoma means the cancer has spread from the skin to the nearby tissue and lymph nodes. The symptoms of advanced melanoma may not appear until years after the diagnosis and removal of the original melanoma. For some people, a change to an existing mole or freckle, or a change in normal‐looking skin is the first sign. General symptoms of advanced melanoma may include weight loss, loss of appetite and fatigue. Melanoma is the fifth most common cancer in the UK with a third of people diagnosed under the age of 55 years.
PV-10 is an investigational new medicinal product that contains 10% rose bengal disodium. PV-10 is given as an injection directly into the affected skin lesion. PV-10 acts by destroying tumour cells and inducing the body’s immune response against tumour cells. PV-10 is being developed for the treatment of locally advanced cutaneous melanoma in patients who are not candidates for targeted therapy and/or an immune checkpoint inhibitor (treatments that help the body recognise and attack cancer cells). If licensed, PV-10 may offer a new treatment option for this patient group with a potential of durable local control and restricted toxicity to the injection site.
Nivolumab is a type of immunotherapy that is currently licensed in the UK for the treatment of several types of advanced cancers such as melanoma, non‐small cell lung cancer, and kidney cancer. It blocks a protein called programmed death-1 (PD-1), which is found on the surface of a type of immune cells called T-cells. Blocking PD-1 stimulates the T-cells to kill the cancer cells. Temozolomide in combination with radiotherapy is currently licensed in the UK for newly diagnosed glioblastoma in adults. The addition of nivolumab to temozolomide and radiotherapy will potentially offer an additional first line treatment option for adult patients who are newly diagnosed MGMT-methylated glioblastoma.