Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens
Condition: Squamous Cell Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the objective response rate (change in tumor size from
      baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer
      treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women ≥18 years of age

          -  Patients with histologically or cytologically documented squamous cell nonsmall-cell
             lung cancer 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 multimodal therapy
             (radiation therapy, surgical resection, or definitive chemoradiation for locally
             advanced disease

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

          -  Disease progression or recurrence after both a platinum doublet-based chemotherapy
             regimen and at least 1 additional systemic therapy

          -  Measurable disease by computed tomography scan/magnetic resonance imaging as per
             Response Evaluation Criteria in Solid Tumors, volume 1.1

        Exclusion Criteria:

          -  Untreated central nervous system (CNS) metastases. Metastases have been treated and
             patients 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,
             patients must have stopped taking corticosteroids or be taking a stable or decreasing
             dose of ≤10 mg prednisone daily (or equivalent)

          -  Carcinomatous meningitis

          -  Active known or suspected autoimmune disease or 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 costimulation or checkpoint
             pathways

          -  A condition requiring systemic treatment with corticosteroids or other
             immunosuppressive medications within 14 days of first dose of study drug