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.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721759
First received: November 2, 2012
Last updated: October 13, 2014
Last verified: June 2014

November 2, 2012
October 13, 2014
November 2012
January 2014   (final data collection date for primary outcome measure)
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
Primary endpoint of investigator-assessed Objective response rate (ORR) [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
Defined as the number of subjects with a confirmed best overall response (BOR) of Complete response (CR) or Partial response (PR) divided by the number of treated subjects
Complete list of historical versions of study NCT01721759 on ClinicalTrials.gov Archive Site
The secondary endpoint of ORR as assessed by investigator [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
The secondary endpoint of ORR as assessed by Independent radiology review committee (IRC) [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Squamous Cell Non-small Cell Lung Cancer
Drug: Nivolumab (BMS-936558)
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
Intervention: Drug: Nivolumab (BMS-936558)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
February 2015
January 2014   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Italy,   Germany
 
NCT01721759
CA209-063, 2012-003965-16
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP