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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Trial Summary
Trial Overview
Inclusion Criteria

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
We found this trial at
36
sites
Cedars-Sinai Medical Center
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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University of Alabama at Birmingham
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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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-1933
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Boston, MA
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Cleveland Clinic
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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Cleveland, OH
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-936-8606
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Columbia University
116th St and Broadway
New York, New York 10027
(212) 854-1754
Phone: 212-304-5530
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Lehigh Valley Health Network
Allentown, Pennsylvania 18105
Phone: 610-402-0636
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Allentown, PA
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Johns Hopkins University School of Medicine
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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Dana-Farber Cancer Institute
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4876
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-9016
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Levine Cancer Institute
Charlotte, North Carolina 28211
Phone: 980-442-5300
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Charlotte, NC
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Erlanger Oncology & Hematology - Univ. Of Tn
Chattanooga, Tennessee 37403
Phone: 423-778-2982
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Local Institution
Chicago, Illinois 60637
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The Ohio State University, Wexner Medical Center
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-685-2435
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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University of Texas Southwestern Medical Center
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-1929
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Henry Ford Health System
Detroit, Michigan 48202
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Preston Robert Tisch Brain Tumor Center at Duke University
Durham, North Carolina 27710
Phone: 919-681-9932
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JFK Medical Center
Edison, New Jersey
Phone: 732321700061689
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Edison, NJ
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Hackensack University Medical Center
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 551-996-5098
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Local Institution
Liverpool, New South Wales 2170
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UCLA Neuro-Oncology Program
Los Angeles, California 90095
Phone: 310-794-3521
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Norton Cancer Institute
Louisville, Kentucky 40207
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University of Miami, Sylvester Comprehensive Cancer Center
1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
Phone: 305-243-3111
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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Yale University School of Medicine
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Phone: 203-785-7486
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Memorial Sloan Kettering Cancer Center
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-610-0239
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Thomas Jefferson University
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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Philadelphia, PA
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St. Joseph Hospital and Medical Center
Phoenix, Arizona 85013
Phone: 602-406-7709
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Sutter Institute for Medical Research
Sacramento, California 95816
Phone: 916-453-5800
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Washington University School of Medicine
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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Huntsman Cancer Institute
Salt Lake City, Utah 84112
Phone: 801-587-4433
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Sharp Memorial Hospital
7901 Frost Street
San Diego, California 92123
858-939-3400
Phone: 619-502-3241
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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The Regents of the University of California, San Francisco
San Francisco, California 94115
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Swedish Neuroscience Institute
Seattle, Washington 98122
Phone: 206-386-3878
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Moffitt Cancer Center
Tampa, Florida 33612
Phone: 813-745-7991
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Georgetown University
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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University of Kansas Medical Center
Westwood, Kansas 66205
Phone: 913-588-1886
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