What is the purpose of this trial?
The drugs being combined in this study are nivolumab (Opdivo TM) and ipilimumab (Yervoy). You have already received nivolumab (Opdivo TM), or another drug that blocks the PD-1 pathway (e.g. pembrolizumab, Keytruda; atezolizumab, Tecentriq). When effective, PD-1 blockers such as these may release brakes on your immune system present in the tumor, allowing it to attack and control your cancer. It is thought that one reason why patients might not respond to PD-1 blockers is because not enough immune cells (called T cells) have made it into the tumor, where brakes are in place. The medication ipilimumab blocks the cytotoxic T-lymphocyte antigen (CTLA-4) pathway which may help bring these kinds of immune cells into the tumor. Furthermore, ipilimumab may help release other brakes on the immune system present in the tumor. The combination of nivolumab and ipilimumab is currently approved by the United States Food and Drug Administration (FDA) for the treatment of metastatic melanoma, and is more effective against melanoma than either medication alone. Early results of trials of this combination in your kind of cancer have been promising and reasonably safe, but it is not known what effects this combination will have in patients who have already received PD-1 blockers with subsequent tumor growth. This study will provide us with more information about whether this combination is effective in your kind of tumor.
Start Date: 06/29/2017
End Date: 11/01/2019
Last Updated: 03/07/2019
Study HIC#: 2000020343