Vanderbilt-Ingram Cancer Center

Participants are being asked to take part in this research study because they have advanced or metastatic squamous cell non-small cell lung cancer (NSCLC). The purpose of this research to study an investigational drug called BMS-936558 (anti-PD-1 antibody) which is being developed by Bristol-Myers Squibb (also known as BMS). BMS-936558 is an antibody (a type of human protein) that is being tested to see if it will allow the body-s immune system to work against tumor cells. BMS would like to find out what effect, good or bad, the study drug has on men and women with metastatic squamous non-small cell lung cancer that cannot be treated by surgery, if the study drug can have an effect on the body-s immune response to a tumor, how the body-s immune response may change over the course of study treatment, if the study drug will cause a tumor to change size and if the study drug can cause the immune system to respond to the drug itself.

Criteria
 For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

 Inclusion Criteria:

 • Men and Women ≥18 years of age

 • Subjects with histologically- or cytologically-documented squamous cell NSCLC who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multi-modal therapy (radiation therapy, surgical resection or definitive chemoradiation for locally advanced disease

 • Eastern Cooperative Oncology Group (ECOG) PS 0 or 1

 • Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least one additional systemic therapy

 • Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

 Exclusion Criteria:

 • Untreated central nervous system (CNS) metastases. Subjects are eligible if metastases are treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent)

 • Subjects with carcinomatous meningitis

 • Active known or suspected autoimmune disease or subjects with interstitial lung disease

 • Prior treatment on either arm of study CA209-017 or CA184-104

 • Prior therapy with anti-Programmed death-1 (anti-PD-1), anti-Programmed cell death ligand 1 (anti-PD-L1), anti-Programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

 • Subjects with a condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug