A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/19/2018
Start Date:April 21, 2016
End Date:June 30, 2022

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A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

The primary objective of this study is to compare PFS (progression-free survival) rate at 6
months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab
240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and
Sq).


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Histologically or cytologically documented Squamous or non-Squamous Non-small cell
lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following
multimodal therapy

- Patients must have received pre-study nivolumab for up to 12 months and have 2
consecutive tumor assessments confirming Complete response (CR), Partial response
(PR), or Stable disease (SD)

- Measurable disease before start of pre-study nivolumab treatment

- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2

Exclusion Criteria:

- Carcinomatous meningitis

- Untreated, symptomatic Central nervous system (CNS) metastases

- Symptomatic interstitial lung disease

Other protocol defined inclusion/exclusion criteria could apply
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1150 N 35th Ave # 330
Hollywood, Florida 33021
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Phone: 605-322-3082
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Vallejo, California 94589
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Abilene, Texas 79606
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Amarillo, Texas 79106
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Athens, Georgia 30607
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6501 Truxtun Avenue
Bakersfield, California 93309
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Baton Rouge, Louisiana 70809
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BellFlower, California 90706
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Phone: 301-571-2016
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Birmingham, Alabama 35223
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Brewer, Maine 04412
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Canton, Ohio 44708
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Charleston, South Carolina 29403
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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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Cleveland, Ohio 44109
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Clifton Park, New York 12065
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1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
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John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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Dallas, Texas 75246
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Denton, Texas 76210
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El Paso, Texas 79902
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Falls Church, Virginia 22042
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Flower Mound, Texas 75028
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Fort Collins, Colorado 80528
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Fort Myers, Florida 33916
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Fort Wayne, Indiana 46845
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Fullerton, California 92835
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Germantown, Tennessee 38138
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1 Ingalls Drive
Harvey, Illinois 60426
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Johnson City, New York 13790
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Lone Tree, Colorado 80218
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Los Angeles, California 90095
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Marietta, Georgia 30060
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Massillon, Ohio 44646
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Medford, Oregon 97504
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Midland, Texas 79701
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Minneapolis, Minnesota 55405
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Niles, Illinois 60714
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Ocala, Florida 34474
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Omaha, Nebraska 68124
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2603 Kentucky Avenue
Paducah, Kentucky 42003
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Pensacola, Florida 32504
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Peoria, Illinois 61615
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Pinehurst, North Carolina 28374
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Plano, Texas 75093
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Redondo Beach, California 90277
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7901 Frost Street
San Diego, California 92123
858-939-3400
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Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Santa Barbara, California 93105
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Santa Maria, California 93454
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Sherman, Texas 75090
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Southfield, Michigan 48075
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Spokane Valley, Washington 99216
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Springfield, Missouri 65807
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St. Leonards, New South Wales 2065
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Vancouver, Washington 98684
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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Wichita Falls, Texas 76310
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Winchester, Virginia 22601
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2811 Tieton Drive
Yakima, Washington 98902
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