A Phase I Study of BMS-936558 in Combination with Sunitinib or Pazopanib in Patients with Metastatic Renal Cell Carcinoma

Sunitinib and pazopanib are drugs approved to treat an aggressive form of kidney cancer called renal cell carcinoma. Despite these therapies, however, the cancer continues to grow in many patients. Doctors hope that adding another drug to treatment may make it more effective. The purpose of this study is to find the highest dose of an investigational drug called BMS-936558 that can be given safely with sunitinib or pazopanib in patients with metastatic renal cell carcinoma.

BMS-936558 boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s white blood cells. BMS-936558 binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.

Sunitinib and pazopanib are each taken orally (by mouth), while BMS-936558 is given intravenously (by vein). Patients will receive sunitinib or pazopanib (but not both) in addition to BMS-936558.