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A Single-Arm Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens

Phase 2
18 Years
Open (Enrolling)
Squamous Cell Non-small Cell Lung Cancer

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Trial Information

A Single-Arm Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email Please visit 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

- 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

- 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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary endpoint of Independent Radiology Review Committee (IRC)-assessed objective response rate (ORR)

Outcome Description:

Defined as the number of subjects with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of treated subjects

Outcome Time Frame:

18 Months

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

November 2012

Completion Date:

February 2014

Related Keywords:

  • Squamous Cell Non-small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University Hospitals of Cleveland Cleveland, Ohio  44106
University of North Carolina Chapel Hill, North Carolina  27599
The Ohio State University Columbus, Ohio  43210
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Local Institution Baltimore, Maryland  
Local Institution Portland, Oregon  
Vanderbilt Ingram Cancer Center Nashville, Tennessee  37232
Local Institution Corona, California  
Local Institution Springfield, Massachusetts  
Local Institution Duluth, Minnesota  
Local Institution Duncansville, Pennsylvania  
Local Institution Arlington, Virginia  
Winship Cancer Institute, Emory University Atlanta, Georgia  30322
Local Institution Detroit, Michigan  
Beth Israel Comprehensive Cancer Center New York, New York  
Oncology Consultants, PA Houston, Texas  77024
Metairie Oncologist, LLC Metairie, Louisiana  70006
Providence Oncology And Hematology Portland, Oregon  97213
Network Office of Research and Innovation Allentown, Pennsylvania  18103