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.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01642004
First received: July 9, 2012
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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:
  • ORR as determined by the IRC [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Objective response rate (ORR) as determined by the Independent Review Committee (IRC) is defined as the number of subjects whose best confirmed objective response is a complete response (CR) or partial response (PR) divided by the number of randomized subjects

  • Overall Survival (OS) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    OS is defined as the time from randomization to the date of death


Secondary Outcome Measures:
  • PFS as assessed by the IRC of BMS-936558 (Nivolumab) versus Docetaxel [ Time Frame: Up to 24 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 as determined by the IRC (per RECIST 1.1) or death due to any cause

  • Potential association between PD-L1 expression and efficacy endpoints measured by ORR and OS [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Durability of and time to objective response measured by DOR and time to objective response (TTR) in BMS-936558 (Nivolumab) and Docetaxel groups [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

    Duration of objective response (DOR) is defined as the time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1) as assessed by the IRC or death due to any cause

    TTR is defined as the time from randomization to the date of the first confirmed CR or PR as assessed by the IRC


  • QoL measured by disease-related symptom improvement rate in BMS-936558 (Nivolumab) and Docetaxel groups [ Time Frame: Day 1 of scheduled cycle for first 6 months, then every 6 weeks thereafter on treatment (approximately 24 months) and at first two follow-up visits ] [ 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: October 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 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®

  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/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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642004

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, California
City Of Hope
Duarte, California, United States, 91010-3000
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 Ctr
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, 02214
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
Columbia University Medical Center
New York, New York, United States, 10032
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, 26506-9162
Argentina
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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Buenos Aires, Argentina, 1417
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Buenos Aires, Argentina, C1280AEB
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Cordoba, Argentina, X5002AOQ
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Tucuman, Argentina, CPT4000IAK
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
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
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Quebec
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Montreal, Quebec, Canada, H3T 1E2
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Rimouski, Quebec, Canada, G5L 5T1
Chile
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Santiago, Metropolitana, Chile, 7600448
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Recoleta, Santiago de Chile, Chile
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Vina 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
France
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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
Germany
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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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Krefeld, Germany, 47805
Hungary
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Budapest, Hungary, H-1121
Ireland
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Dublin 8, Dublin, Ireland
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Dublin 9, Dublin, Ireland
Italy
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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
Mexico
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Mexico, Distrito Federal, Mexico, 06735
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Tlalpan, Distrito Federal, Mexico, 14080
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Leon, Guanajato, Guanajuato, Mexico, 37000
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Hermosillo, Sonora, Mexico, 83280
Netherlands
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Amsterdam, Netherlands, 1066 CX
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Rotterdam, Netherlands, 3015 CE
Norway
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Oslo, Norway, 0310
Peru
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Arequipa, Peru, 54
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Lima, Peru, L-27
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Lima, Peru, 34
Poland
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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
Romania
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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
South Africa
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Port Elizabeth, Eastern Cape, South Africa, 6045
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Parktown, Gauteng, South Africa, 2193
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Cape Town, Western Cape, South Africa, 7570
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George, Western Cape, South Africa, 6530
Spain
Local Institution
Barakaldo, Spain, 48903
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Barcelona, Spain, 08035
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Madrid, Spain, 28050
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Madrid, Spain, 28040
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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
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Withington, Manchester, United Kingdom, M20 4BX
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Sheffield, Yorkshire, United Kingdom, S10 2SJ
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: NCT01642004     History of Changes
Other Study ID Numbers: CA209-017, 2011-004792-36
Study First Received: July 9, 2012
Last Updated: April 1, 2014
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 Publica 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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014