Intermittent Therapy in Metastatic Renal Cell Carcinoma Patients Treated With Ipilimumab and Nivolumab
Status:
Recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
Summary
This study is being done with patients with advanced kidney cancer (also called renal cell
carcinoma or RCC). This is a research study involving the use of the drug Nivolumab (also
known as Opdivo®). Nivolumab is an anti-PD-1 antibody. It works by attaching to and blocking
a molecule called PD-1. PD-1 is a protein that is present on different types of cells in the
immune system and controls parts of the immune system by shutting it down. Antibodies that
block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing
it to recognize and help destroy cancer cells. In many countries (including the United
States, European Union and Japan) Nivolumab is approved to treat certain cancer types. The
purpose of the study is to test the safety and effectiveness of nivolumab in patients with
advanced RCC when given intermittently.
Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of
advanced kidney cancer, non small cell lung cancer, classical Hodgkin Lymphoma and Metastatic
Melanoma. Nivolumab is FDA-approved for advanced RCC because has been shown to shrink RCC
tumors that have spread outside the kidney.