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: July 23, 2014
Last verified: June 2014
  Purpose

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)

  Eligibility

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

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
  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 ClinicalTrials.gov identifier: NCT01721759

  Hide Study Locations
Locations
United States, California
University Of California, Davis Medical Center
Sacramento, California, United States, 95817
Va San Diego Healthcare System
San Diego, California, United States, 92161
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Louisiana
Local Institution
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Providence Cancer Institute
Southfield, Michigan, United States, 48075
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Beth Israel Comprehensive Cancer Center
New York, New York, United States, 10011
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
University Hospitals Of Cleveland
Cleveland, Ohio, United States, 44106
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Providence Oncology And Hematology
Portland, Oregon, United States, 97213
United States, Pennsylvania
Network Office Of Research And Innovation
Allentown, Pennsylvania, United States, 18103
University Of Pittsburgh Medical Center
Pittburgh, Pennsylvania, United States, 15232
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Oncology Consultants, Pa
Houston, Texas, United States, 77024
France
Local Institution
Caen, France, 14000
Local Institution
Creteil, France, 9410
Local Institution
Pierre Benite, France, 69495
Local Institution
Rennes, France, 35033
Local Institution
Strasbourg, France, 67090
Local Institution
Toulouse, France, 31059
Local Institution
Villejuif, France, 94800
Germany
Local Institution
Berlin, Germany, 13125
Local Institution
Koeln, Germany, 50937
Local Institution
Muenchen, Germany, 80336
Italy
Local Institution
Livorno, Italy, 57100
Local Institution
Lucca, Italy, 55100
Local Institution
Terni, Italy, 05100
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01721759     History of Changes
Other Study ID Numbers: CA209-063, 2012-003965-16
Study First Received: November 2, 2012
Last Updated: July 23, 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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014