Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: July 9, 2012
Last updated: November 17, 2015
Last verified: November 2015
The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

Condition Intervention Phase
Squamous Cell Non-small Cell Lung Cancer
Biological: Nivolumab
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall Survival (OS) of BMS-936558 (Nivolumab) versus Docetaxel in subjects with squamous cell NSCLC after failure of prior-platinum doublet-based chemotherapy [ Time Frame: 38 months ] [ Designated as safety issue: No ]
    OS is defined as the time from randomization to the date of death

Secondary Outcome Measures:
  • ORR of BMS-936558 (Nivolumab) versus Docetaxel [ Time Frame: 38 months ] [ Designated as safety issue: No ]
    Objective response rate (ORR) is defined as the number of subjects whose best confirmed objective response is either a complete response (CR) or partial response (PR) divided by the number of randomized subjects

  • PFS of BMS-936558 (Nivolumab) versus Docetaxel [ Time Frame: 38 months ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause

  • Potential association between PD-L1 expression and efficacy measures (ORR, OS PFS) will be assessed [ Time Frame: 38 Months ] [ Designated as safety issue: No ]
  • QoL measured by disease-related symptom improvement rate in BMS-936558 (Nivolumab) and Docetaxel groups [ Time Frame: 38 Months ] [ Designated as safety issue: No ]
    Quality of life (QoL) is defined as the proportion of randomized subjects who had a disease-related symptom improvement as measured by the Lung Cancer Symptom Scale (LCSS)

Estimated Enrollment: 264
Study Start Date: September 2012
Estimated Study Completion Date: January 2017
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Name: BMS-936558
Experimental: Arm B: Docetaxel
Docetaxel 75 mg/m2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Drug: Docetaxel
Other Name: Taxotere®


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/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease)
  • Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
  • Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • An formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient

Exclusion Criteria:

  • Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline 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
  • Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
  • Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • Prior treatment on the first line study CA184104 first line NSCLC study
  • Prior treatment with Docetaxel
  • Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • Treatment with any investigational agent within 14 days of first administration of study treatment
  Contacts and Locations
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Please refer to this study by its identifier: NCT01642004

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United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, California
City Of Hope National Medical Center
Duarte, California, United States, 91010
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Northwest Georgia Oncology Center, P.C.
Marietta, Georgia, United States, 30060
United States, Illinois
University Of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Columbia University Medical Center
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
St Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Guthrie Clinic, Ltd
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29210
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
University Of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United States, West Virginia
West Virginia University-Mbrcc
Morgantown, West Virginia, United States, 26506
Local Institution
Capital Federal, Buenos Aires, Argentina, 1431
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Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, CP1426ANZ
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San Miguel De Tucuman, Tucuman, Argentina, CPT4000IAK
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Buenos Aires, Argentina, 1417
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Buenos Aires, Argentina, C1280AEB
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Cordoba, Argentina, X5002AOQ
Australia, New South Wales
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Wollongong, New South Wales, Australia, 2500
Australia, South Australia
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Adelaide, South Australia, Australia, SA 5000
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Elizabeth Vale, South Australia, Australia, 5112
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Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
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East Bentleigh, Victoria, Australia, 3165
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Linz, Austria, 4020
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Salzburg, Austria, 5020
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Vienna, Austria, 1130
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Wels, Austria, 4600
Canada, Manitoba
Cancercare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Centre De Sante Et De Services Sociaux Rimouski Neigette
Rimouski, Quebec, Canada, G5L 5T1
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Santiago, Metropolitana, Chile, 7600448
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Recoleta, Santiago de Chile, Chile
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Vi?a Del Mar, Valparaiso, Chile
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Antofagasta, Chile, 240000
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Santiago, Chile, 7630370
Czech Republic
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Praha 8, Czech Republic, 180 81
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Avignon Cedes 9, France, 84918
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Caen, France, 14000
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Dijon, France, 21000
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La Roche Sur Yon Cedex 9, France, 85925
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Lyon Cedex 08, France, 69373
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Marseille Cedex 20, France, 13915
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Pierre Benite, France, 69495
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Rennes Cedex 9, France, 35033
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Strasbourg, France, 67090
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Toulouse, France, 31300
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Bad Berka, Germany, 99437
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Essen, Germany, 45122
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Gerlingen, Germany, 70839
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Grosshansdorf, Germany, 22927
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Heidelberg, Germany, 69126
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Koeln, Germany, 51109
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Budapest, Hungary, H-1121
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Dublin 8, Dublin, Ireland
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Dublin 9, Dublin, Ireland
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Bologna, Italy, 40138
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Meldola (fc), Italy, 47014
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Milano, Italy, 20133
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Padova, Italy, 35128
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Perugia, Italy, 06132
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Ravenna, Italy, 48100
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Siena, Italy, 53100
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Mexico, Distrito Federal, Mexico, 06735
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Mexico City, Distrito Federal, Mexico, 14080
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Leon, Guanajato, Guanajuato, Mexico, 37000
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Hermosillo, Sonora, Mexico, 83280
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Amsterdam, Netherlands, 1066 CX
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Rotterdam, Netherlands, 3015 CE
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Arequipa, Peru, 54
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Lima, Peru, 34
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Lima, Peru, L-27
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Gdansk, Poland, 80-952
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Krakow, Poland, 31-202
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Olsztyn, Poland, 10-513
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Szczecin, Poland, 70-891
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Warszawa, Poland, 02-781
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Bucuresti, Romania, 010976
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Cluj-Napoca, Romania, 400352
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Constanta, Romania, 900591
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Craiova, Romania, 200385
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Iasi, Romania, 700106
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Timisoara, Romania, 300167
Russian Federation
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Moscow, Russian Federation, 115 478
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St. Petersburg, Russian Federation, 198255
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Barakaldo, Spain, 48903
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Barcelona, Spain, 08035
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Madrid, Spain, 28040
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Madrid, Spain, 28050
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Sevilla, Spain, 41013
United Kingdom
Local Institution
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
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Southampton, Hampshire, United Kingdom, SO16 6YD
Local Institution
Withington, Manchester, United Kingdom, M20 4BX
Local Institution
Sheffield, Yorkshire, United Kingdom, S10 2SJ
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb Identifier: NCT01642004     History of Changes
Other Study ID Numbers: CA209-017  2011-004792-36 
Study First Received: July 9, 2012
Last Updated: November 17, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Data Protection Authority
Norway: Directorate of Health
Peru: Instituto Nacional de Salud
Poland: National Institute of Medicines
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on February 11, 2016