An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)



Status:Active, not recruiting
Conditions:Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:May 5, 2016
End Date:August 1, 2023

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A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated
(the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus
radiation therapy. They will be compared to patients receiving nivolumab in addition to
temozolomide plus radiation therapy.


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

Inclusion Criteria:

- Males and Females, age ≥ 18 years old

- Newly diagnosed brain cancer or tumor called glioblastoma or GBM

- Karnofsky performance status of ≥ 70 (able to take care of self)

- Substantial recovery from surgery resection

- Tumor test result shows MGMT methylated or indeterminate tumor subtype

Exclusion Criteria:

- Biopsy-only of GBM with less than 20% of tumor removed

- Prior treatment for GBM (other than surgical resection)

- Any known tumor outside of the brain

- Recurrent or secondary GBM

- Active known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply
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Westwood, Kansas 66205
Phone: 913-588-1886
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-934-1842
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-1933
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-445-3407
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-4513
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Allentown, Pennsylvania 18105
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28211
Phone: 980-442-5300
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Chattanooga, Tennessee 37403
Phone: 423-778-2982
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Chicago, Illinois 60637
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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Detroit, Michigan 48202
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Durham, North Carolina 27710
Phone: 919-681-9932
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Edison, New Jersey
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Liverpool, New South Wales 2170
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Los Angeles, California 90095
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Louisville, Kentucky 40207
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
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University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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1275 York Ave
New York, New York 10021
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-503-9110
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona 85013
Phone: 602-406-7709
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Sacramento, California 95816
Phone: 916-453-5800
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-286-0896
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84112
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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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Seattle, Washington 98122
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Tampa, Florida 33612
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Phone: 202-687-8962
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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