This is a clinical trial of a new treatment for prostate cancer that is a type of vaccine
that could be a new way to treat cancer. A vaccine that could alert the immune system to the
presence of cancer cells in the body may enable the immune system to target and kill those
cells effectively. This vaccine is intended to work by making the immune system kill cells
that have a special protein (called 5T4) that is present on the surface of cancer cells. The
vaccine is made up of two recombinant viruses ("ChAdOx1"- chimpanzee adenovirus Ox1 and "MVA"
- modified vaccinia Ankara) that have been designed to produce the 5T4 protein and have been
modified so that they are weakened and cannot reproduce themselves within the body like
normal viruses. Once injected into the body, these viruses make the 5T4 protein and help the
body's immune system to learn to target this protein and destroy cancer cells.
This vaccine will be used in combination with the immunotherapy drug called nivolumab which
is an anti-PD-1 (Programmed Death protein-1) monoclonal antibody. This is a molecule that
releases the brakes on the immune system and helps the immune system to kill cancer cells
more efficiently. Nivolumab as a monotherapy was approved for treatment of several tumour
types but not for the prostate cancer.
This study will evaluate the safety and efficacy of ChAdOx1-MVA 5T4 vaccine in combination
with nivolumab in low and intermediate risk prostate cancer patients who have elected to have
their prostate removed and in patients with advanced metastatic prostate cancer.