Clinical Trials

Study of BMS-936558 in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens

Location:

Scottsdale and Phoenix,  AZ,  Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

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

Who is eligible to participate?

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 recurrent disease following radiation therapy or surgical resection

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

- Disease progression or recurrence after both first-line platinum doublet chemotherapy and at least one United States-Food and Drug Administration (US FDA) or European Medicines Agency (EMA)-approved subsequent line of 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:

- Active Central nervous system (CNS) metastases. Subjects are eligible if metastases are adequately 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 CA209017 or CA184104

- 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

Last updated: 03/29/2013

NCT ID: NCT01721759

IRB Number:13-000210