Oesophageal cancer is the sixth most common cause of cancer deaths in the world and is more prevalent in men than in women.
The majority of patients are diagnosed with advanced/metastatic cancer (cancer which has spread), and in this setting, response to chemotherapy is poor. Given the high incidence and mortality worldwide and lack of good
therapeutic options, oesophageal cancer patients represent a high unmet need for drug development.
This is a phase III, randomised, double blind, placebo controlled trial of a study drug pembrolizumab in combination with cisplatin and 5-fluorouracil compared to placebo (dummy drug) in combination with cisplatin and 5-fluorouracil as first-line treatment for oesophageal cancer.
The purpose of the trial is to evaluate how effective and safe pembrolizumab is in combination with chemotherapy compared with placebo and chemotherapy.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells come upon cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. Interaction between these ligands and the receptors present on the immune cells prevents the immune cells from attacking the cancer cells. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.