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



Status:Active, not recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:October 10, 2012
End Date:January 23, 2020

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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)

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

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

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 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
We found this trial at
35
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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Columbia, SC
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Seattle, WA
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Capital Federal, Buenos Aires
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Capital Federal,
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Chattanooga, Tennessee 37404
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Cincinnati, OH
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, California 91010
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Houston, Texas 77030
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Kennewick, Washington 99336
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7360 W. Deschutes
Kennewick, Washington 99336
509-783-0144
Columbia Basin Hematology and Oncology Our collaboration with Seattle Cancer Care Alliance gives you convenient...
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Langhorne, Pennsylvania 19047
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Marietta, Georgia 30060
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Morgantown, West Virginia 26506
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Nashville, Tennessee 37232
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19111
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San Diego, California 92123
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San Francisco, California 94115
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Sayre, Pennsylvania 18840
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Sayre, Pennsylvania 18840
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Seattle, Washington 98104
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Tampa, Florida 33612
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