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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Trial Summary
Trial Overview
Inclusion Criteria

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
We found this trial at
69
sites
Sacred Heart medical Oncology Group
Pensacola, Florida 32504
Phone: 850-416-4611
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Florida Cancer Specialists
3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Phone: 239-274-9930
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Memorial Cancer Institute at Memorial Regional Hospital
1150 N 35th Ave # 330
Hollywood, Florida 33021
Phone: 310-794-3424
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Avera Cancer Institute
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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Kaiser Permanente Medical Center
Vallejo, California 94589
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Texas Oncology, P.A.
Abilene, Texas 79606
Phone: 281-863-4631
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Texas Oncology, P.A. -Amarillo
Amarillo, Texas 79106
Phone: 281-863-4631
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University Cancer and Blood Center LLC
Athens, Georgia 30607
Phone: 7063532990279
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CBCC Global Research
6501 Truxtun Avenue
Bakersfield, California 93309
Phone: 310-794-3424
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Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
Phone: 225-215-1129
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Southern California Permanente Medical Group
BellFlower, California 90706
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Center for Cancer & Blood Disorders
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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Alabama Oncology
Birmingham, Alabama 35223
Phone: 205-803-4369
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Cancer Care of Maine
Brewer, Maine 04412
Phone: 207-973-4249
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Hematology and Oncology Associates, Inc.
Canton, Ohio 44708
Phone: 330-489-1274
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Charleston Hematology/Oncology Associates, Pa
Charleston, South Carolina 29403
Phone: 281-863-4631
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Oncology Hematology Care
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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Metrohealth Cancer Care Center
Cleveland, Ohio 44109
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New York Oncology Hematology
Clifton Park, New York 12065
Phone: 281-863-4631
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John B. Amos Cancer Center
1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
Phone: 706-320-8752
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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Texas Oncology, PA
Dallas, Texas 75246
Phone: 281-863-4631
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Texas Oncology, P.A.
Denton, Texas 76210
Phone: 281-863-4631
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Texas Oncology
El Paso, Texas 79902
Phone: 281-863-4631
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Innova Schar Cancer Institute
Falls Church, Virginia 22042
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Texas Oncology, P.A.
Flower Mound, Texas 75028
Phone: 281-863-4631
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Poudre Valley Health Care, Inc.
Fort Collins, Colorado 80528
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Florida Cancer Specialists S.
Fort Myers, Florida 33916
Phone: 239-274-9930
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Ft. Wayne Med Onco-Hema Inc
Fort Wayne, Indiana 46845
Phone: 310-794-3424
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St Jude Hospital Yorba Linda
Fullerton, California 92835
Phone: 310-206-0179
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Fullerton, CA
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The Jones Clinic, PC
Germantown, Tennessee 38138
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Ingalls Health System
1 Ingalls Drive
Harvey, Illinois 60426
Phone: 708-915-6120
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Texas Oncology
Houston, Texas 77024
Phone: 281-863-4631
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Innova Schar Cancer Institute
Indianapolis, Indiana 46237
Phone: 317-528-7819
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Broome Oncology, LLC
Johnson City, New York 13790
Phone: 281-863-4631
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Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado 80218
Phone: 281-863-4631
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Texas Oncology PA ( Site 8001)
Longview, Texas 75601
Phone: 281-863-4631
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UCLA Hematology/Oncology Clinic
Los Angeles, California 90095
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Northwest Georgia Oncology Center
Marietta, Georgia 30060
Phone: 770-281-5124
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Tri-County Hematology and Oncology Associates
Massillon, Ohio 44646
Phone: 330-489-1274
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Hematology Oncology Consultants, Pc
Medford, Oregon 97504
Phone: 281-863-4631
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Texas Oncology-Midland Allison Cancer Center
Midland, Texas 79701
Phone: 281-863-4631
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Minnesota Oncology and Hematology, PA
Minneapolis, Minnesota 55405
Phone: 281-863-4631
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Tennessee Oncology, PLLC
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Phone: 615-524-4025
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Illinois Cancer Specialists
Niles, Illinois 60714
Phone: 281-863-4631
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Ocala Oncology Center Pl
Ocala, Florida 34474
Phone: 352-732-4032
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Oncology Hematology West
Omaha, Nebraska 68124
Phone: 281-863-4631
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Oncology Associated Of Western Kentucky
2603 Kentucky Avenue
Paducah, Kentucky 42003
Phone: 310-794-3424
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Illinois Cancercare, Pc
Peoria, Illinois 61615
Phone: 309-243-3663
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Arizona Oncology Assoc, Pc-Hal
Phoenix, Arizona 85016
Phone: 281-863-4631
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Arizona Oncology Associates PC - NAHOA
Phoenix, Arizona 85016
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First Health of the Carolinas
Pinehurst, North Carolina 28374
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Texas Oncology
Plano, Texas 75093
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Torrance Health Association
Redondo Beach, California 90277
Phone: 310-794-3424
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Texas Oncology, P.A.
San Antonio, Texas 78217
Phone: 281-863-4631
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Sharp Memorial Hospital
7901 Frost Street
San Diego, California 92123
858-939-3400
Phone: 858-939-5062
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Sansum Clinic
Santa Barbara, California 93105
Phone: 281-863-4631
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Central Coast Medical Oncology
Santa Maria, California 93454
Phone: 310-794-3424
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Texas Oncology, P.A.
Sherman, Texas 75090
Phone: 281-863-4631
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Providence Cancer Center
Southfield, Michigan 48075
Phone: 248-849-3198
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Cancer Care Northwest
Spokane Valley, Washington 99216
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Mercy Medical Research Institute
Springfield, Missouri 65807
Phone: 417-820-4587
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Local Institution
St. Leonards, New South Wales 2065
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Texas Oncology, P.A.
Sugar Land, Texas 77479
Phone: 281-863-4631
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North Mississippi Medical Center
Tupelo, Mississippi 38801
Phone: 662-377-4629
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Northwest Cancer Specialists
Vancouver, Washington 98684
Phone: 281-863-4631
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Cancer Center of Kansas
818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Phone: 310-206-0179
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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Texas Oncology, PA
Wichita Falls, Texas 76310
Phone: 281-863-4631
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Shenandoah Oncology P.C
Winchester, Virginia 22601
Phone: 281-863-4631
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Yakima Valley Memorial Hospital/North Star Lodge
2811 Tieton Drive
Yakima, Washington 98902
Phone: 281-863-4631
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