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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 (CheckMate 063)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: November 2, 2012
Last updated: December 31, 2014
Last verified: June 2014

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 Nivolumab (BMS-936558) after failure of two prior systemic regimens

Condition Intervention Phase
Squamous Cell Non-small Cell Lung Cancer
Drug: Nivolumab (BMS-936558)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Primary endpoint of Independent Radiology Review Committee (IRC)-assessed objective response rate (ORR) [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    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

Secondary Outcome Measures:
  • The secondary endpoint of ORR as assessed by investigator [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: February 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Nivolumab (BMS-936558)
Nivolumab (BMS-936558) will be dosed intravenously (IV) over 60 minutes at 3 mg/kg every two weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Drug: Nivolumab (BMS-936558)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01721759

  Show 33 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb Identifier: NCT01721759     History of Changes
Other Study ID Numbers: CA209-063, 2012-003965-16
Study First Received: November 2, 2012
Last Updated: December 31, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on February 25, 2015