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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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
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New York, New York 10032
Phone: 212-342-2959
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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
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-7716
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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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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
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1211 Medical Center Dr
Nashville, Tennessee 37232
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733 North Broadway
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450 Brookline Ave
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171 Ashley Avenue
Charleston, South Carolina 29425
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Chattanooga, Tennessee 37403
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281 W. Lane Ave
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1801 Inwood Rd
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Detroit, Michigan 48202
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1515 Holcombe Blvd
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Liverpool, New South Wales 2170
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1475 NW 12th Ave
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333 Cedar Street
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1275 York Ave
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1020 Walnut St
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3800 Reservoir Rd NW
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