A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/16/2018
Start Date:February 28, 2014
End Date:January 31, 2022

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A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen

The purpose of this study is to estimate the incidence and characterize the outcome of high
grade, select adverse events in subjects with advanced or metastatic NSCLC treated with
Nivolumab.


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

1. Target Population

- Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or
nonsquamous (NSQ)] who present with Stage IIIB/Stage IV disease (according to version
7 of the International Association for the Study of Lung Cancer Staging Manual in
Thoracic Oncology), or with recurrent or progressive disease following multimodal
therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for
locally advanced disease)

- Subjects must have experienced disease progression or recurrence during or after at
least one systemic therapy for advanced or metastatic disease

- Each subsequent line of therapy must be preceded by disease progression. A switch of
an agent within a regimen in order to manage toxicity does not define the start of a
new line of therapy

- Maintenance therapy following platinum doublet-based chemotherapy is not considered as
a separate regimen of therapy

- Subjects who received platinum-containing adjuvant, neoadjuvant or definitive
chemoradiation therapy given for locally advanced disease, and developed recurrent
(local or metastatic) disease within 6 months of completing therapy are eligible

- Subjects with recurrent disease >6 months after platinum-containing adjuvant,
neoadjuvant or definitive chemoradiation therapy given for locally advanced disease,
who also subsequently progressed during or after a platinum doublet-based regimen
given to treat the recurrence are eligible

- Subjects with non-squamous histology must be tested for Epithelial Growth Factor
Receptor (EGFR) mutations (including, but not limited to, deletions in exon 19 and
exon 21 [L858R] substitution) and Anaplastic Lymphoma Kinase (ALK) rearrangement if
tests have not been previously performed. Subjects with progressive disease during or
after EGFR or ALK tyrosine kinase inhibitor (TKI) regimens are eligible. Subjects are
eligible if genetic test results are indeterminate or if no tumor tissue is available
or accessible for testing as long as they have received one prior systemic therapy

- Experimental therapies when given as separate regimen are considered as separate line
of therapy

- Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria
(radiographic tumor assessment performed within 28 days of first dose of study drug)
or clinically apparent disease that the investigator can follow for response per
RECIST 1.1

- Eastern Cooperative Oncology Arm (ECOG) performance status (PS)

- PS 0 to 1

- PS 2

Exclusion Criteria:

1. Target Disease Exceptions

- Subjects with active central nervous system (CNS) metastases are excluded

- Subjects with carcinomatous meningitis

2. Medical History and Concurrent Diseases

- Subjects with a history of interstitial lung disease

- Subjects with active, known or suspected autoimmune disease

- Subject whom participated in either arm of the following clinical trials
CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with
anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1)
experimental agents

3. Prohibited Treatments and/or Restricted Therapies

- Ongoing or planned administration of anti-cancer therapies other than those
specified in this study

- Use of corticosteroids or other immunosuppressive medications
We found this trial at
127
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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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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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433 Southwest 10th Street
Ocala, Florida 34471
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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490 North Washington Avenue
Titusville, Florida 32796
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Abilene, Texas 79606
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Albany, New York 12208
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Albuquerque, New Mexico 87110
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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Amarillo, Texas 79106
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Ann Arbor, Michigan 48016
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Annapolis, Maryland 21401
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Arlington, Texas 76014
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Asheboro, North Carolina 27203
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Asheville, North Carolina 28801
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Bakersfield, California 93309
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Beaumont, Texas 77702
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Bethlehem, Pennsylvania 18015
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900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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Brewer, Maine 04412
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4802 10th Ave
Brooklyn, New York 11219
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Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Calgary, Alberta
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Charleston, South Carolina 29403
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Chattanooga, Tennessee 37404
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
312.355.1625
University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
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Denton, Texas 76210
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Fort Wayne, Indiana 46845
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Fresh Meadows, New York 11365
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Germantown, Tennessee 38138
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Golden, Colorado 80401
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Goldsboro, North Carolina 27534
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14200 Celebrate Life Way
Goodyear, Arizona 85338
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1631 Lancaster Drive
Grapevine, Texas 76051
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Greenville, South Carolina 29615
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Hattiesburg, Mississippi 39401
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Houston, Texas 77090
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Jackson, Mississippi 39202
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Johnson City, New York 13790
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Kansas City, Kansas 66160
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Lakeland, Florida 33805
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
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Langhorne, Pennsylvania 19047
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Las Vegas, Nevada 89169
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Macon, Georgia 31201
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McAllen, Texas 78503
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Midland, Texas 79701
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259 1st St
Mineola, New York 11501
(516) 663-0333
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Mobile, Alabama 36608
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Mount Kisco, New York 10549
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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, Tennessee 37232
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320 E North Ave
Pittsburgh, Pennsylvania 15212
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Plano, Texas 75075
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Quincy, Illinois 62301
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3330 Lomita Boulevard
Redondo Beach, California 90277
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