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Clinical Trials

Topic   Stage IV Non-Small Cell Lung Cancer (NSCLC)
Title   A Study of Nivolumab in Combination with Ipilimumab (part 1); and Nivolumab plus Ipilimumab in Combination with Chemotherapy vs. Chemotherapy alone (part 2) as First Line Therapy in stage IV Non-Small Cell Lung Cancer (NSCLC)
Summary   Nivolumab and Ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will stimulate the body’s immune system to work against tumor cells. PD-L1 (programmed death), is a cell surface molecule which interacts with certain other molecules to decrease the function and further production of immune system cells called T-cells. Nivolumab has been shown to have a higher response rate against tumors which produce this molecule in measurable quantities (are PD-L1+). Ipilimumab is an antibody that acts against CTLA-4 (a protein receptor that acts as an “off” switch for the immune system). An antibody against CTLA-4 can stop CTLA-4 from turning off the immune system which allows the immune response to continue.
Nivolumab (Opdivo ™) has been approved by the FDA (Food and Drug Administration) for the treatment of metastatic melanoma (a type of skin cancer), and previously treated advanced lung and kidney cancers. Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma. For more information, please visit www.clinicaltrials.gov
Description   The main purpose of this study is to see if Nivolumab in combination with Ipilimumab increases the chance of positive response (complete or partial) in treating lung cancer. It will also test the effectiveness (how well the drug works), safety, and tolerability of the Nivolumab and Ipilimumab combination in patients with advanced non-small cell lung cancer (NSCLC).
IRB Number   16020
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following:
  • This study is for patients age 18 and older.
  • Histologically confirmed stage IV NSCLC
  • No prior systemic therapy for stage IV disease.
  • Patients must have tumor tissue sample available at central lab
  • 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. For example, patients must be well enough that they would be able to carry out office work or light housework.
Status   Open
Start Date   06/02/2016
Principal Name   Jeffery Schneider, MD
Contact Name   Dawn Tsushima, Research Nurse Coordinator
Email   dtsushima@nyuwinthrop.org
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-4895
Alternate Phone   516-663-8391