Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:February 10, 2016
End Date:April 20, 2022

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Trial Summary
Trial Overview
Inclusion Criteria

A Study of Nivolumab in Combination With Ipilimumab (Part 1); and Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)

The purpose of part 1 of this study is to determine the objective response rate (ORR) in
stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line
therapy.

The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab
and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.


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

Inclusion Criteria:

- Men and Women ≥ 18 years of age

- Diagnosed with stage IV Non-Small Cell Lung Cancer

- Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous
concurrent chemoradiation with no further curative options.

Exclusion Criteria:

- Subjects with untreated CNS metastases are excluded.

- Subjects with carcinomatous meningitis

- Subjects with an active, known or suspected autoimmune disease.

- Subjects with a condition requiring systemic treatment with either corticosteroids ( >
10 mg daily prednisone

equivalent) or other immunosuppressive medications within 14 days of first treatment.

- Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
30
sites
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Beth Israel Deaconess Medical Center
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Duke University
Durham, North Carolina 27710
(919) 684-8111
Phone: 919-681-4768
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Cleveland Clinic Florida
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Lovelace Cancer Care
Albuquerque, New Mexico 87102
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Albuquerque, NM
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New Mexico Cancer Care Alliance
Albuquerque, New Mexico 87109
Phone: 505-925-0411
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Albuquerque, NM
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New Mexico Hematology Oncology Consultants
Albuquerque, New Mexico 87109
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Albuquerque, NM
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The Cancer Center at Presbyterian
Albuquerque, New Mexico 87110
Phone: 706-721-2505
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Albuquerque, NM
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Presbyterian Rust Medical Center
2400 Unser Boulevard Southeast
Albuquerque, New Mexico 87131
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Winship Cancer Institute
Atlanta, Georgia 30322
Phone: 404-778-4576
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Atlanta, GA
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Johns Hopkins Cancer Center
1800 Orleans Street
Baltimore, Maryland 21287
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Baltimore, MD
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Dana-Farber Cancer Institute
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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Charleston Hematology/Oncology Associates, Pa
Charleston, South Carolina 29403
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Charleston, SC
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Ohio State University
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-293-9424
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Henry Ford Health System
Detroit, Michigan 48202
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Hackensack University Medical Center
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 551-996-5900
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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Kingston Regional Cancer Centre
Kingston, Ontario
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Nebraska Hematology-Oncology, PC
Lincoln, Nebraska 68506
Phone: 402-484-4908
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Lincoln, NE
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University of Louisville Medical Center
Louisville, Kentucky 40202
Phone: 502-217-5229
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Louisville, KY
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Winthrop University Hospital
259 1st St
Mineola, New York 11501
(516) 663-0333
Phone: 517-663-4895
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Tennessee Oncology, PLLC
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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Memorial Sloan Kettering Cancer Center
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4863
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Allegheny Health Network
PIttsburgh, Pennsylvania 15212
Phone: 412-235-1316
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Cancer Center of Central Connecticut
Plainville, Connecticut
Phone: 860-621-9316
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Plainville, CT
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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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San Diego, CA
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Summit Cancer Care
Savannah, Georgia 31405
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Cancer Center of Kansas
818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Phone: 316-262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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Novant Health Oncology Specialists
Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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