A Phase III Study of Nivolumab and Ipilimumab, Together and Individually, in Patients Newly Diagnosed with Advanced Melanoma

The purpose of this study is to compare the effectiveness of the drugs nivolumab and ipilimumab given together with each drug given with a placebo in patients with previously untreated inoperable or metastatic melanoma. Ipilimumab is already approved for treating melanoma. Nivolumab (also called BMS-936558) is investigational. Prior research has shown that the combination of these two drugs can be very effective for shrinking melanoma tumors.

Nivolumab 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. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.

Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that an antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune response that may help the body to destroy cancer cells.

Patients in this study will be randomly assigned to receive one of three treatments: nivolumab and ipilimumab, nivolumab and a placebo, or ipilimumab plus a placebo. All treatments are given intravenously (by vein).