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
Full Description
CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057
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
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There are 110 Locations for this study
Scottsdale Arizona, 85259, United States
Duarte California, 91010, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
New Haven Connecticut, 06520, United States
Tampa Florida, 33612, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Lebanon New Hampshire, 03756, United States
Mineola New York, 11501, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45242, United States
Langhorne Pennsylvania, 19047, United States
Philadelphia Pennsylvania, 19111, United States
Sayre Pennsylvania, 18840, United States
Columbia South Carolina, 29210, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Kennewick Washington, 99336, United States
Seattle Washington, 98104, United States
Seattle Washington, 98109, United States
Morgantown West Virginia, 26506, United States
Capital Federal Buenos Aires, 1426, Argentina
Capital Federal Buenos Aires, 1431, Argentina
Ciudad De Buenos Aires Buenos Aires, C1181, Argentina
Buenos Aires , C1280, Argentina
La Rioja , 5300, Argentina
Tweed Heads New South Wales, 2485, Australia
Woolloongabba Queensland, 4102, Australia
Adelaide South Australia, 5000, Australia
Kurralta Park South Australia, 5037, Australia
Frankston Victoria, 3199, Australia
Melbourne Victoria, 3065, Australia
Linz , 4020, Austria
Salzburg , 5020, Austria
Vienna , 1130, Austria
Wels , 4600, Austria
Salvador Bahia, 40170, Brazil
Fortaleza Ceara, 60336, Brazil
Porto Alegre Rio Grande Do Sul, 90020, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Barretos Sao Paulo, 14784, Brazil
Rio De Janeiro , 20231, Brazil
Edmonton Alberta, T6G 1, Canada
London Ontario, N6A 4, Canada
Rimouski Quebec, G5L 5, Canada
Santiago Metropolitana, 76004, Chile
Santiago Metropolitana, , Chile
Recoleta Santiago De Chile, , Chile
Viña Del Mar Valparaiso, , Chile
Praha 8 , 180 8, Czechia
Creteil , 94010, France
Dijon Cedex , 21079, France
La Roche Sur Yon Cedex 9 , 85925, France
Lyon Cedex 08 , 69373, France
Marseille Cedex 20 , 13915, France
Poitiers , 86000, France
Rennes Cedex 9 , 35033, France
Toulouse , 31300, France
Bad Berka , 99437, Germany
Grosshansdorf , 22927, Germany
Heidelberg , 69126, Germany
Koeln , 51109, Germany
Mainz , 55131, Germany
Recklinghausen , 45657, Germany
Stuttgart , 70376, Germany
Ulm , 89081, Germany
Hong Kong , , Hong Kong
Budapest , H-112, Hungary
Bergamo , 24127, Italy
Bologna , 40138, Italy
Meldola (fc) , 47014, Italy
Milano , 20133, Italy
Padova , 35128, Italy
Parma , 43100, Italy
Perugia , 06132, Italy
Ravenna , 48100, Italy
Siena , 53100, Italy
Mexico Distrito Federal, 06735, Mexico
Mexico Distrito Federal, 14080, Mexico
Monterrey Nuevo Leon, 64060, Mexico
Hermosillo Sonora, 83280, Mexico
Oslo , 0424, Norway
Miraflores Lima, 18, Peru
Arequipa , 54, Peru
Lima , 34, Peru
Lima , L-27, Peru
Krakow Małopolskie, 30-00, Poland
Gdansk , 80-19, Poland
Olsztyn , 10-51, Poland
Szczecin , 70891, Poland
Warszawa , 02-78, Poland
Bucuresti , 01097, Romania
Cluj-Napoca , 40035, Romania
Craiova , 20038, Romania
Iasi , 70010, Romania
Timisoara , 30016, Romania
Moscow , 115 4, Russian Federation
St. Petersburg , 19702, Russian Federation
Singapore , 16961, Singapore
Singapore , 30843, Singapore
Barcelona , 08035, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Sevilla , 41013, Spain
Vizcaya , 48903, Spain
Basel , 4031, Switzerland
Chur , 7000, Switzerland
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