Neo-N

The Neo-N Clinical Trial

The body’s immune system is made up of many types of white blood cells that protect against infections. Lymphocytes are an immune cell that attacks foreign invaders, like bacteria or viruses. Special lymphocytes called T-cells can attack the body’s own cells that have been affected by something foreign. Cancer cells are sometimes seen as foreign by T-cells and other lymphocytes. These immune cells invade the tumour and attack the cancer cells. However, some cancer cells avoid attack by the body’s immune system using “immune checkpoints”.

One immune checkpoint is “Programmed Cell Death Protein 1” or PD-1. PD-1 exists on the surface of the T-cells and can stop the T-cells from attacking. Some cancer cells can make proteins that signal PD-1 and stop the T-cells.

Nivolumab is a PD-1 antibody (also known as a “PD-1 inhibitor”). It blocks PD-1 from being signalled and helps the T-cells actively fight cancer cells. This gives the body’s immune cells more of a chance to find and attack the cancer cells.

Another immune checkpoint is the “anti-lymphocyte activation gene 3” or LAG-3. LAG-3 is a protein that also exists on the surface of T-cells and helps control T-cell response, activation and growth. If T-cells have to work for a long time (e.g. where there is chronic infection or cancer) they become tired and stop being able to grow and continue to fight. This process is called T-cell exhaustion and is associated with an increase in LAG-3.

Relatlimab is a LAG-3 inhibitor. It reduces the amount of LAG-3 and may help T-cells recover from exhaustion and continue to fight cancer cells.

Immune checkpoint inhibitors have often been used with standard chemotherapy treatments. However, standard chemotherapy can reduce the immune system and may make it harder for the immune checkpoint inhibitors to work on the cancer. Researchers want to find out if this is the case by giving nivolumab and relatlimab first on their own and then at the same time as standard chemotherapy.

The Neo-N clinical trial will involve 16 sites in Australia and New Zealand and will enrol up to 54 patients in the study.

Prof Sherene Loi is the Study Chair for the Neo-N clinical trial.

Australia

Ballarat Oncology & Haematology Services

Coffs Harbour Health Campus

Flinders Medical Centre

Frankston Hospital

Peter MacCallum Cancer Centre

Riverina Cancer Care Centre

Royal North Shore Hospital

St George Hospital

St John of God Hospital, Bunbury

St Vincent’s Hospital, Melbourne

Sydney Adventist Hospital

Toowoomba Hospital

New Zealand

Waikato Hospital

Europe (Italy)

ICS Maugeri

IRST MEldola

Instituto Europeo di Oncologia

S.C. Oncologia ASO