The purpose of this study is to compare the investigational drug BMS-936558 (nivolumab) with standard chemotherapy in patients with inoperable or metastatic melanoma that has continued to grow despite anti-CTLA-4 therapy and (if a patient’s tumor has a BRAF mutation) prior vemurafenib therapy.
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.
In this study, patients will be randomly assigned to receive BMS-936558 or standard chemotherapy (dacarbazine or paclitaxel plus carboplatin).