The purpose of this study is to determine the safety and effectiveness of giving the drug nivolumab alone and in combination with ipilimumab in patients with advanced triple-negative breast, pancreatic, small cell lung, or stomach (gastric) cancers that have continued to grow or have returned following prior therapy.
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 mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks 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 at the right time. Ipilimumab is already approved for treating melanoma, and prior studies have shown that combining it with nivolumab can be very effective for shrinking melanoma tumors. Nivolumab is also approved for treating melanoma, as well as some metastatic squamous cell lung cancers. The use of nivolumab and ipilimumab for treating other cancers is considered investigational.
Patients in this study will be randomly assigned to receive nivolumab alone or nivolumab plus ipilimumab.