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.
Nivolumab and ipilimumab, both administered by intravenous infusion, are immune therapy medicinal products that are currently licensed as a combination treatment of advanced cancers such as melanoma and kidney cancer. Nivolumab is a medicinal product called an immune checkpoint inhibitor. It works by improving the activity of white blood cells (T-cells), thereby increasing the ability of the immune system to kill cancer cells. Ipilimumab has a different mode of action but also increases the activity of T-cells against the cancer cells. If licensed, nivolumab in combination with ipilimumab may offer an additional first-line treatment option for PD-L1 positive patients with previously untreated, unresectable or metastatic urothelial cancer.