BMS CA209-153

Nivolumab is an antibody (type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells. Nivolumab is investigational, which means it is not approved by the US Food and Drug Administration. Approximately 780 participants will take part in this study. It is expected that participants will be in the study for approximately 6.5 years. The exact length depends on the participant’s response to treatment. Those who choose to take part will receive nivolumab, which is admininstered by intravenous infusion (through a vein). The infusion usually takes about an hour (60 minutes). The first dose of nivolumab will be given at Day 1. Thereafter, it will be administered every 2 weeks, depending on the participant’s response to the drug. There are 3 periods to this study: Screening, treatment and follow-up. The screening period can take between 3 and 30 days to complete. During the screening visit, the following tests and procedures will be performed: review of medical history; review of medications currently being taken and have been taken in the past (including herbal medications); physical examination; review of symptoms; collection of blood (approximately 4 teaspoons) for laboratory tests (for blood chemistry, including kidney and liver function, count red and white blood cells and platelets, measure thyroid function, and check for hepatitis B and C infection); blood sample for pharmacogenomics will be collected prior to the first treatment; test for EGFR mutations and ALK rearrangement (if non-squamous histology) if they were not previously performed; pregnancy test for women of childbearing potential; biopsy tissue will be reviewed to determine if the cells have certain features (if biopsy was not done or tissue is not available, the participant will need to have a biopsy of tumor tissue in order to participate in this study); computed tomography scan (CT) or magnetic resonance imaging (MRI) of the known areas of disease; and a brain scan (CT or MRI) may be performed (as determined by the study doctor).   The next visit will be the baseline visit. At the baseline visit, the following tests and procedures will be performed: review of any health changes and medications since the last visit; thyroid function test; measurement of weight, vital signs and oxygen level; questionnaires will be completed (questions relating to the participant’s symptoms and the impact they have had on their daily lives); collection of urine or blood sample for a pregnancy test for women of childbearing potential; and collection of blood for biomarker tests (about 1 teaspoon). Follow-up visits will occur after treatment with nivolumab has been stopped. The first two follow-up visits will be at the doctor’s office. The first one will be about a month after the treatment has been stopped, and the second will be about two months after the first follow-up visit. The remaining follow-up visits can be done at the doctor’s office or over the telephone. The remaining follow-up visits will occur approximately every 3 months.