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A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients (CheckMate 143)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02017717
First Posted: December 23, 2013
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Recurrent Glioblastoma Biological: Nivolumab Biological: Bevacizumab Biological: Ipilimumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Cohorts 1,1b, 1c and 1d : Safety and tolerability based on drug related events leading to permanent discontinuation prior to completing 4 doses [ Time Frame: Approximately up to 8 months ]
  • Cohort 2: Overall Survival (OS) [ Time Frame: Approximately 36 months ]

    OS of Nivolumab versus Bevacizumab.

    Overall Survival is defined as the time between the date of randomization and the date of death due to any cause



Secondary Outcome Measures:
  • Cohort 2: Overall Survival rate (OS) [ Time Frame: Approximately 36 months ]
    Comparing OS between Nivolumab and Bevacizumab

  • Cohort 2: Progression Free Survival (PFS) [ Time Frame: Approximately 36 months ]

    Comparing PFS between Nivolumab and Bevacizumab

    PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause


  • Cohort 2: Objective Response Rate(ORR) [ Time Frame: Approximately 36 months ]

    Comparing ORR between Nivolumab and Bevacizumab

    ORR is defined as the number of subjects whose best overall response (BOR) is Complete Response (CR) or Partial Response (PR) divided by all randomized subjects



Enrollment: 626
Actual Study Start Date: January 27, 2014
Estimated Study Completion Date: January 31, 2018
Primary Completion Date: January 10, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm N:Nivolumab
Cohort 1, 1c, 1d and 2: Nivolumab 3mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity
Biological: Nivolumab
Other Name: BMS-936558
Experimental: Arm N + I:Nivolumab + Ipilimumab

Cohort 1: Nivolumab 1mg/kg + Ipilimumab 3mg/kg intravenously every 3 weeks x 4 doses, then Nivolumab 3mg/kg every 2 weeks until disease progression or unacceptable toxicity

Cohort 1b: Nivolumab 3mg/kg + Ipilimumab 1mg/kg intravenously every 3 weeks for 4 doses, then Nivolumab 3mg/kg every 2 weeks thereafter until disease progression or unacceptable toxicity

Biological: Nivolumab
Other Name: BMS-936558
Biological: Ipilimumab
Other Name: Yervoy
Active Comparator: Arm B: Bevacizumab
Cohort 2: Bevacizumab 10 mg/kg intravenously once every 2 weeks until disease progression or unacceptable toxicity
Biological: Bevacizumab
Other Name: Avastin

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017717


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3410
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
UCLA Neuro-Oncology Program
Los Angeles, California, United States, 90095-1769
The Regents of the University of California, San Francisco
San Francisco, California, United States, 94143-0372
United States, Colorado
Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Maryland
Johns Hopkins University School Of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10022
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Preston Robert Tisch Brain Tumor Center at Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Australia, New South Wales
Local Institution
Liverpool, New South Wales, Australia, 2017
Australia, Victoria
Local Institution
East Bentleigh, Victoria, Australia, 3165
Local Institution
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Belgium
Local Institution
Brussels, Belgium, 1090
Local Institution
Bruxelles, Belgium, 1200
Denmark
Aarhus University Hospital
Aarhus C, Denmark, 8000
Odense University Hospital
Odense C, Denmark, 5000
France
Local Institution
Bobigny, France, 93000
Local Institution
Bron cedex, France, 69677
Local Institution
Marseille Cedex 5, France, 13385
Local Institution
Paris cedex 13, France, 75651
Germany
Universitaetsklinikum Bonn
Bonn, Germany, 53105
Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main
Frankfurt Am Main, Germany, 60528
Local Institution
Heidelberg, Germany, 69120
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Italy
Local Institution
Bologna, Italy, 40139
Local Institution
Milano, Italy, 20133
Local Institution
Siena, Italy, 53100
Local Institution
Torino, Italy, 10126
Netherlands
Local Institution
Amsterdam, Netherlands, 1066CX
Local Institution
Groningen, Netherlands, 9713 GZ
Poland
Local Institution
Gdansk, Poland, 80-952
Local Institution
Warszawa, Poland, 02-781
Spain
Local Institution
Barcelona, Spain, 08035
Local Institution
Madrid, Spain, 28009
Local Institution
Madrid, Spain, 28041
Local Institution
Pamplona, Spain, 31008
Switzerland
Centre hospitalier universitaire Vaudois (CHUV)
Lausanne, Switzerland, BT 02252
UniversitaetsSpital Zurich
Zuerich, Switzerland, 8091
United Kingdom
Local Institution
London, Greater London, United Kingdom, NW1 2PG
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4BX
Local Institution
Wirral, Merseyside, United Kingdom, L63 4JY
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02017717     History of Changes
Other Study ID Numbers: CA209-143
2013-003738-34 ( EudraCT Number )
First Submitted: December 17, 2013
First Posted: December 23, 2013
Last Update Posted: October 31, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Nivolumab
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors