An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)



Status:Recruiting
Conditions:Cancer, Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:February 29, 2016
End Date:October 1, 2019
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated
(the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every
two weeks in addition to radiation therapy, and then every four weeks. They will be compared
to patients receiving standard therapy with temozolomide in addition to radiation therapy.


For more information regarding BMS 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

- Tumor test result shows MGMT unmethylated type

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

Exclusion Criteria:

- 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

- Biopsy with less than 20% of tumor removed
We found this trial at
42
sites
Lehigh Valley Health Network
Allentown, Pennsylvania 18105
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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
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Boston, MA
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University of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-7716
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-636-9410
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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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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Los Angeles, CA
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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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Nashville, TN
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Emory University/Winship Cancer Institute
Atlanta, Georgia 30322
Phone: 404-778-4520
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Atlanta, GA
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Johns Hopkins University School of Medicine
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Phone: 410-955-7504
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Local Institution
Boston, Massachusetts 02111
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Boston, MA
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Local Institution
Boston, Massachusetts 02111
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Boston, MA
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Local Institution
Boston, Massachusetts 02111
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Boston, MA
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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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Boston, MA
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-572-9211
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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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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Chattanooga, TN
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Ohio State University
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-685-2435
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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University of Texas Southwestern Medical Center
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-5874
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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Detroit, MI
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Preston Robert Tisch Brain Tumor Center at Duke University
Durham, North Carolina 27710
Phone: 919-684-7574
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Durham, NC
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JFK Medical Center
Edison, New Jersey
Phone: 732-321-7000
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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
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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University of Texas M.D. Anderson Cancer Center
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Phone: 713-745-5769
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Local Institution
Liverpool, New South Wales 2170
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Liverpool,
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UCLA Neuro-Oncology Program
Los Angeles, California 90095
Phone: 310-825-5321
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Los Angeles, CA
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Norton Cancer Institute
Louisville, Kentucky 40207
Phone: 502-629-4417
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Louisville, KY
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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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Miami, FL
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Yale Cancer Center
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Phone: 203-785-5917
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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Memorial Sloan Kettering Cancer Center
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Columbia University Medical Center (Cumc)
New York, New York 10032
Phone: 212-342-2959
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New York, NY
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Local Institution
Oklahoma City, Oklahoma 73103
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Oklahoma City, OK
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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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Phoenix, AZ
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Sutter Institute for Medical Research
Sacramento, California 95816
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Washington University School of Medicine
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Huntsman Cancer Institute
Salt Lake City, Utah 84112
Phone: 801-587-4433
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Salt Lake City, UT
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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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The Regents of the University of California, San Francisco
San Francisco, California 94115
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Swedish Neuroscience Institute
Seattle, Washington 98122
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Seattle, WA
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Moffitt Cancer Center
Tampa, Florida 33612
Phone: 813-745-7991
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Tampa, FL
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Georgetown University Medical Center
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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University of Kansas Medical Center
Westwood, Kansas 66205
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Westwood, KS
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