Full TitleA Pilot Study of Neoadjuvant Nivolumab in High-Risk, Non-Metastatic, Renal Cell Carcinoma (NCI #9913)
The purpose of this study is to assess the safety and feasibility of giving the immunotherapy drug nivolumab before surgery in patients with renal cell carcinoma that has a high risk of coming back or spreading, but has not metastasized. Nivolumab is already approved to treat metastatic renal cell cancer; its use in earlier stages of the disease is considered investigational.
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. It is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have operable clear cell renal cell carcinoma that has not yet been treated and has not metastasized.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.