Nivolumab is in development for the treatment of a type of bladder cancer that is at high risk of spreading beyond the lining of the bladder into the surrounding muscle. Bladder cancer starts when cells that make up the urinary bladder start to grow out of control. As more cancer cells develop, they can form a tumour and, with time, spread to other parts of the body. Urothelial cancer is the most common type of bladder cancer. High risk invasive urothelial cancer is when there is a greater chance for the cancer cells spreading to the lymph glands around the bladder and therefore patients have a reduced chance of cure.
Nivolumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells. Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer. By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells. If licenced for the adjuvant treatment of high risk invasive urothelial carcinoma, nivolumab has the potential to increase the length of time until the cancer comes back.
Nivolumab in combination with ipilimumab is in clinical development for PD-L1 positive patients with previously untreated unresectable or metastatic urothelial cancer regardless of cisplatin eligibility. Urothelial cancer, a subset of bladder cancer, occurs on the lining of the renal pelvis, ureter, bladder and urethra, and other parts of the urinary system. In some cases,the tumour spreads into the surrounding muscles or other parts of the body which means that it cannot be cured by surgery. Metastatic urothelial cancer occurs when the cancer has spread to other parts of the body, such as the liver or bones. The symptom of urothelial cancer is blood in the urine, but symptoms may only appear once the cancer grows larger or into the deeper layers of the bladder wall for both men and women. Other symptoms may include increased frequency/urgency/pain of urine passing, weight loss, back/lower tummy/bone pain, fatigue and illness.