Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC (CheckMate 057)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01673867
First received: August 24, 2012
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy


Condition Intervention Phase
Non-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 Metastatic Non-squamous 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 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Overall Survival is defined as the time from randomization to the date of death

  • Overall Survival [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Year 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) of BMS-936558 (Nivolumab) versus Docetaxel [ Time Frame: 6, 12, 18, 24, 36, 48 months and 5 year ] [ Designated as safety issue: No ]
    ORR is defined as the proportion of all randomized subjects whose best overall response (BOR) from baseline is either a Complete response (CR) or Partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

  • Progression-free survival (PFS) of BMS-936558 (Nivolumab) versus Docetaxel [ Time Frame: 6, 12, 18, 24, 36, 48 months and 5 year ] [ Designated as safety issue: No ]
    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

  • PD-L1 protein expression [ Time Frame: 6, 12, 18, 24, 36, 48 months and 5 year ] [ Designated as safety issue: No ]
    PD-L1 expression is defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay

  • Disease-related symptom improvement rate [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    Measured by LCSS, in BMS-936558 (nivolumab) and docetaxel treatment groups


Estimated Enrollment: 574
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (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 (Anti-PD1)
Active Comparator: Arm B: Docetaxel
Docetaxel 75 mg/m² concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Drug: Docetaxel
Other Name: Taxotere®

Detailed Description:

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

  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 & women ≥18 years of age
  • Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for 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 RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • A 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 asymptomatic or 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 ≤10mg daily prednisone (or equivalent)
  • Subjects with carcinomatous meningitis
  • Subjects with active,or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment 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 (anti-PD-1), anti programmed cell death ligand 1 (anti-PD-L1), anti programmed cell death ligand 2 (anti-PD-L2), anti-cluster of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • Prior treatment with Docetaxel
  • Treatment with any investigational agent within 14 days of first administration of study treatment
  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: NCT01673867

  Hide Study Locations
Locations
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
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
San Francisco Oncology Associates
San Francisco, California, United States, 94115
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
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
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
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29210
United States, Tennessee
Tennessee Oncology, Pllc
Chattanooga, Tennessee, United States, 37404
Henry-Joyce Cancer Center
Nashville, Tennessee, United States, 37232
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
United States, Texas
University Of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Univ Of Tx. Md Anderson
Houston, Texas, United States, 77030
United States, Washington
Columbia Basin Hematology And Oncology
Kennewick, Washington, United States, 99336
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
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, 1431
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Capital Federal, Buenos Aires, Argentina, 1426
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Ciudad De Buenos Aires, Buenos Aires, Argentina, C1181ACH
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Buenos Aires, Argentina, C1280AEB
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Buenos Aires, Argentina, 1417
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La Rioja, Argentina, 5300
Australia, New South Wales
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Tweed Head, New South Wales, Australia, 2485
Australia, Queensland
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Brisbane, Queensland, Australia, 4102
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
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Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
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Frankston, Victoria, Australia, 3199
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Melbourne, Victoria, Australia, 3065
Austria
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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
Brazil
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Salvador, Bahia, Brazil, 40170
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Fortaleza, Ceara, Brazil, 60336
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610
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Porto Alegre, Rio Grande Do Sul, Brazil, 90020
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Barretos, Sao Paulo, Brazil, 14784
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Rio De Janeiro, Brazil, 20231
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution
London, Ontario, Canada, N6A 4L6
Canada, Quebec
Centre De Sante Et De Services Sociaux Rimouski Neigette
Rimouski, Quebec, Canada, G5L 5T1
Chile
Local Institution
Santiago, Metropolitana, Chile, 7600448
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Santiago, Metropolitana, Chile
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Recoleta, Santiago de Chile, Chile
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Vi?a Del Mar, Valparaiso, Chile
Czech Republic
Local Institution
Praha 8, Czech Republic, 180 81
France
Local Institution
Creteil, France, 94010
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Dijon Cedex, France, 21079
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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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Poitiers, France, 86000
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Rennes Cedex 9, France, 35033
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Toulouse, France, 31300
Germany
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Bad Berka, Germany, 99437
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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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Mainz, Germany, 55131
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Recklinghausen, Germany, 45657
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Ulm, Germany, 89081
Hong Kong
Local Institution
Hong Kong, Hong Kong
Hungary
Local Institution
Budapest, Hungary, H-1121
Italy
Local Institution
Bergamo, Italy, 24127
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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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Parma, Italy, 43100
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Perugia, Italy, 06132
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Ravenna, Italy, 48100
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Siena, Italy, 53100
Mexico
Local Institution
Tlalpan, Distrito Federal, Mexico, 14080
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Monterrey, Nuevo Leon, Mexico, 64060
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Hermosillo, Sonora, Mexico, 83280
Norway
Local Institution
Oslo, Norway, 0424
Peru
Local Institution
Miraflores, Lima, Peru, 18
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Arequipa, Peru, 54
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Lima, Peru, 34
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Lima, Peru, L-27
Poland
Local Institution
Gdansk, Poland, 80-19
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Krakow, Poland, 31-202
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Olsztyn, Poland, 10-513
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Szczecin, Poland, 70891
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Warszawa, Poland, 02-781
Romania
Local Institution
Bucuresti, Romania, 010976
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Cluj-Napoca, Romania, 400352
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Craiova, Romania, 200385
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Iasi, Romania, 700106
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Timisoara, Romania, 300167
Russian Federation
Local Institution
Moscow, Russian Federation, 129128
Local Institution
Moscow, Russian Federation, 115 478
Local Institution
St. Petersburg, Russian Federation, 197022
Singapore
Local Institution
Singapore, Singapore, 169610
Local Institution
Singapore, Singapore, 308433
Spain
Local Institution
Barcelona, Spain, 08035
Local Institution
Madrid, Spain, 28040
Local Institution
Madrid, Spain, 28050
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Sevilla, Spain, 41013
Local Institution
Vizcaya, Spain, 48903
Switzerland
Local Institution
Basel, Switzerland, 4031
Local Institution
Chur, Switzerland, 7000
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: NCT01673867     History of Changes
Other Study ID Numbers: CA209-057, 2012-002472-14
Study First Received: August 24, 2012
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration
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
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
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
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Federal Office of Public Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014