Lung Cancer Clinical Trial

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

Summary

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

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Full Description

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

View Eligibility Criteria

Eligibility Criteria

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 hormone replacement, or 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

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

792

Study ID:

NCT01673867

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 110 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Scottsdale Arizona, 85259, United States
City Of Hope
Duarte California, 91010, United States
Sharp Clinical Oncology Research
San Diego California, 92123, United States
San Francisco Oncology Associates
San Francisco California, 94115, United States
Yale University
New Haven Connecticut, 06520, United States
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
Northwest Georgia Oncology Center, P.C.
Marietta Georgia, 30060, United States
University Of Chicago Medical Center
Chicago Illinois, 60637, United States
The Johns Hopkins University
Baltimore Maryland, 21287, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Winthrop University Hospital Oncology/Hematology
Mineola New York, 11501, United States
Memorial Sloan Kettering Nassau
New York New York, 10065, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Oncology Hematology Care, Inc.
Cincinnati Ohio, 45242, United States
St. Mary Medical Center
Langhorne Pennsylvania, 19047, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Guthrie Medical Group, P.C.
Sayre Pennsylvania, 18840, United States
South Carolina Oncology Associates
Columbia South Carolina, 29210, United States
Tennessee Oncology, PLLC - SCRI - PPDS
Chattanooga Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
University Of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Kadlec Clinical Hematology and Oncology
Kennewick Washington, 99336, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
University of Washington - Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
West Virginia University-Mbrcc
Morgantown West Virginia, 26506, United States
Local Institution
Capital Federal Buenos Aires, 1426, Argentina
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Capital Federal Buenos Aires, 1431, Argentina
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Ciudad De Buenos Aires Buenos Aires, C1181, Argentina
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Buenos Aires , C1280, Argentina
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La Rioja , 5300, Argentina
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Tweed Heads New South Wales, 2485, Australia
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Woolloongabba Queensland, 4102, Australia
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Adelaide South Australia, 5000, Australia
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Kurralta Park South Australia, 5037, Australia
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Frankston Victoria, 3199, Australia
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Melbourne Victoria, 3065, Australia
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Linz , 4020, Austria
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Salzburg , 5020, Austria
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Vienna , 1130, Austria
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Wels , 4600, Austria
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Salvador Bahia, 40170, Brazil
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Fortaleza Ceara, 60336, Brazil
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Porto Alegre Rio Grande Do Sul, 90020, Brazil
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Porto Alegre Rio Grande Do Sul, 90610, Brazil
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Barretos Sao Paulo, 14784, Brazil
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Rio De Janeiro , 20231, Brazil
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
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London Ontario, N6A 4, Canada
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski Quebec, G5L 5, Canada
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Santiago Metropolitana, 76004, Chile
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Santiago Metropolitana, , Chile
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Recoleta Santiago De Chile, , Chile
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Viña Del Mar Valparaiso, , Chile
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Praha 8 , 180 8, Czechia
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Creteil , 94010, France
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Dijon Cedex , 21079, France
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La Roche Sur Yon Cedex 9 , 85925, France
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Lyon Cedex 08 , 69373, France
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Marseille Cedex 20 , 13915, France
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Poitiers , 86000, France
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Rennes Cedex 9 , 35033, France
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Toulouse , 31300, France
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Bad Berka , 99437, Germany
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Grosshansdorf , 22927, Germany
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Heidelberg , 69126, Germany
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Koeln , 51109, Germany
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Mainz , 55131, Germany
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Recklinghausen , 45657, Germany
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Stuttgart , 70376, Germany
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Ulm , 89081, Germany
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Hong Kong , , Hong Kong
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Budapest , H-112, Hungary
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Bergamo , 24127, Italy
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Bologna , 40138, Italy
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Meldola (fc) , 47014, Italy
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Milano , 20133, Italy
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Padova , 35128, Italy
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Parma , 43100, Italy
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Perugia , 06132, Italy
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Ravenna , 48100, Italy
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Siena , 53100, Italy
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Mexico Distrito Federal, 06735, Mexico
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Mexico Distrito Federal, 14080, Mexico
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Monterrey Nuevo Leon, 64060, Mexico
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Hermosillo Sonora, 83280, Mexico
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Oslo , 0424, Norway
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Miraflores Lima, 18, Peru
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Arequipa , 54, Peru
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Lima , 34, Peru
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Lima , L-27, Peru
Local Institution - 0073
Krakow Małopolskie, 30-00, Poland
Local Institution - 0068
Gdansk , 80-19, Poland
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Olsztyn , 10-51, Poland
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Szczecin , 70891, Poland
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Warszawa , 02-78, Poland
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Bucuresti , 01097, Romania
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Cluj-Napoca , 40035, Romania
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Craiova , 20038, Romania
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Iasi , 70010, Romania
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Timisoara , 30016, Romania
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Moscow , 115 4, Russian Federation
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St. Petersburg , 19702, Russian Federation
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Singapore , 16961, Singapore
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Singapore , 30843, Singapore
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Barcelona , 08035, Spain
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Madrid , 28040, Spain
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Madrid , 28050, Spain
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Sevilla , 41013, Spain
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Vizcaya , 48903, Spain
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Basel , 4031, Switzerland
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Chur , 7000, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

792

Study ID:

NCT01673867

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

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