A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:January 27, 2014
End Date:October 26, 2018

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A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination With Ipilimumab Across Different Lines of Glioblastoma

The purpose of the study is to compare the efficacy and safety of nivolumab administered
alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain
cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab
administered alone or in combination with ipilimumab in patients with different lines of GBM
therapy.

Allocation: Randomized (Cohort 1 and 2), Non-Randomized (Cohorts 1b, 1c and 1d)

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Subjects with histologically confirmed Grade IV malignant glioma

- Previous treatment with radiotherapy and temozolomide (Cohorts 1, 1b and 2 only)

- First recurrence of GBM (Cohorts 1, 1b and 2 only)

- First diagnosis of GBM with resectable disease (Cohorts 1c Part A only)

- First diagnosis of unmethylated MGMT GBM (Cohort 1d and Cohort 1c Part B only)

- Karnofsky performance score of 70 or higher

Exclusion Criteria:

- More than 1 recurrence of GBM (Cohorts 1, 1b and 2 only)

- Any recurrence of GBM (Cohorts 1c and 1d only)

- Presence of extracranial metastatic or leptomeningeal disease

- Active, known or suspected autoimmune disease

- Clinically significant cardiovascular disease

- Prior bevacizumab or other Vascular Endothelial Growth Factor (VEGF) or
anti-angiogenic treatment (Cohort 2 only)
We found this trial at
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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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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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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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)
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
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Atlanta, Georgia 30322
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Aurora, Colorado 80045
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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
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-6749
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
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28211
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Detroit, Michigan 48202
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Durham, North Carolina 27710
Phone: 919-681-4047
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Liverpool, New South Wales 2170
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Los Angeles, California 90095
Phone: 310-794-3521
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Phone: 203-785-5702
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
(212) 639-2000
Phone: 212-639-7523
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
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Rochester, Minnesota 55905
Phone: 855-776-0015
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Seattle, Washington 98122
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Tampa, Florida 33612
Phone: 813-745-1689
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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