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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) (CheckMate 498)

This study is currently recruiting participants.
Verified December 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02617589
First Posted: December 1, 2015
Last Update Posted: December 7, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Brain Cancer Drug: Nivolumab Drug: Temozolomide Radiation: Radiotherapy 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 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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Approximately 3 years ]
    Overall survival: Defined as the time between the date of randomization and the date of death due to any cause


Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: Approximately 24 months ]
    Progression free survival: Defined as the time from randomization to the date of the first documented tumor progression or death due to any cause

  • Overall survival [ Time Frame: Approximately 24 months ]

Estimated Enrollment: 550
Actual Study Start Date: February 29, 2016
Estimated Study Completion Date: October 1, 2019
Estimated Primary Completion Date: March 10, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab + Radiotherapy Arm
Nivolumab IV infusion + Radiotherapy dose as specified
Drug: Nivolumab Radiation: Radiotherapy
Active Comparator: Temozolomide + Radiotherapy Arm
Temozolomide + Radiotherapy dose as specified
Drug: Temozolomide Radiation: Radiotherapy

  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:   18 Years and older   (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:

  • 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
  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): NCT02617589


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35294-3410
United States, Arizona
St. Joseph Hospital And Medical Center Active, not recruiting
Phoenix, Arizona, United States, 85013
United States, California
Cedars Sinai Medical Center Completed
Los Angeles, California, United States, 90048
UCLA Neuro-Oncology Program Completed
Los Angeles, California, United States, 90095-1769
Sutter Institute For Medical Research Active, not recruiting
Sacramento, California, United States, 95816
Sharp Memorial Hospital Completed
San Diego, California, United States, 92123
The Regents of the University of California, San Francisco Active, not recruiting
San Francisco, California, United States, 94143-0372
United States, Connecticut
Yale Cancer Center Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University Medical Center Completed
Washington, District of Columbia, United States, 20007
United States, Florida
University Of Miami Sylvester Comprehensive Cancer Center Active, not recruiting
Miami, Florida, United States, 33136
Moffitt Cancer Center Active, not recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Emory University - Winship Cancer Institute Active, not recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
The University Of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Kansas
University Of Kansas Medical Center Active, not recruiting
Westwood, Kansas, United States, 66205
United States, Kentucky
Norton Cancer Institute Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University School Of Medicine Active, not recruiting
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Dana-Farber Cancer Institute Completed
Boston, Massachusetts, United States, 02215
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Site 0093         
Massachusetts General Hospital Completed
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System Active, not recruiting
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University School Of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
JFK Medical Center Active, not recruiting
Edison, New Jersey, United States, 08820-3947
Hackensack University Medical Center Active, not recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10022
Columbia University Medical Center (Cumc) Active, not recruiting
New York, New York, United States, 10032-2603
United States, North Carolina
Levine Cancer Institute Active, not recruiting
Charlotte, North Carolina, United States, 28204
Preston Robert Tisch Brain Tumor Center at Duke University Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Completed
Cleveland, Ohio, United States, 44195
The Ohio State University Active, not recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Local Institution Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site 0137         
United States, Pennsylvania
Lehigh Valley Health Network Active, not recruiting
Allentown, Pennsylvania, United States, 18103
Thomas Jefferson University Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University Of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Erlanger Oncology & Hematology - Univ. of TN Active, not recruiting
Chattanooga, Tennessee, United States, 37403
Vanderbilt University Medical Center Completed
Nashville, Tennessee, United States, 37232
United States, Texas
University Of Texas Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75390
University Of Texas Md Anderson Cancer Ctr Completed
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute Active, not recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Swedish Neuroscience Institute Active, not recruiting
Seattle, Washington, United States, 98122
Australia, New South Wales
Local Institution Recruiting
Liverpool, New South Wales, Australia, 2017
Contact: Site 0002         
Royal North Shore Hospital Recruiting
St. Leonards, New South Wales, Australia, 2065
Contact: Mustafa Khasraw, Site 0005    +61294631373      
Australia, Victoria
Local Institution Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0003         
Local Institution Recruiting
Prahran, Victoria, Australia, 3181
Contact: Site 0004         
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Anna Nowak, Site 0001    +61408818656      
Austria
Kepler Universitaetsklinikum Recruiting
Linz, Austria, 4020
Contact: Josef Pichler, Site 0061         
Medical University Of Vienna Recruiting
Vienna, Austria, 1090
Contact: Matthias Preusser, Site 0060         
Belgium
Universitair Ziekenhuis Brussel Active, not recruiting
Brussels, Belgium, 1090
Cliniques Universitaires Saint-Luc Active, not recruiting
Bruxelles, Belgium, 1200
Uz Leuven Active, not recruiting
Leuven, Belgium, 3000
Canada, British Columbia
British Columbia Cancer Agency-Vancouver Ctr Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Brian Thiessen, Site 0014    6048776000      
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Warren Mason, Site 0035    4165817823      
Canada, Quebec
Montreal Neurological Institute and Hospital Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Kevin Petrecca, Site 0074    5143982801      
Denmark
Local Institution Active, not recruiting
Copenhagen, Denmark, 2100
Local Institution Active, not recruiting
Odense C, Denmark, 5000
France
Local Institution Active, not recruiting
Bron Cedex, France, 69677
Local Institution Active, not recruiting
Lille Cedex, France, 59037
Local Institution Active, not recruiting
Marseille, France, 13005
Local Institution Active, not recruiting
Paris cedex 13, France, 75651
Local Institution Active, not recruiting
Paris, France, 75010
Local Institution Active, not recruiting
Rennes Cedex, France, 35042
Local Institution Active, not recruiting
Toulouse, France, 31100
Local Institution Active, not recruiting
Vandoeuvre Les Nancy, France, 54500
Germany
Universitaetsklinikum Bonn Recruiting
Bonn, Germany, 53105
Contact: Ulrich Herrlinger, Site 0051    +4922828719887      
Uniklinik Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Martin Uhl, Site 0072    +4991318534640      
Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main Recruiting
Frankfurt am Main, Germany, 60528
Contact: Oliver Baehr, Site 0049    +4969630187711      
Medizinische Universitaetsklinik Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Oliver Schnell, Site 0073    +4976127050010      
Universitaetsklinikum Hamburg Recruiting
Hamburg, Germany, 20246
Contact: Manfred Westphal, Site 0054    +4940741035316      
Universitaetsklinik Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Antje Wick, Site 0052    +4962215638265      
Universitaetsklinik Koeln Recruiting
Koeln, Germany, 50937
Contact: Norbert Galldiks, Site 0139    +492214784015      
Universitaetsklinikum Muenster Recruiting
Muenster, Germany, 48149
Contact: Oliver Grauer, Site 0050         
Klinikum rechts der Isar der Technischen Universitat Munchen Recruiting
Munich, Germany, 81675
Contact: Stephanie Combs, Site 0138         
Bezirksklinikum Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Peter Hau, Site 0055    +499419413290      
Universitasklinikum Tubingen Recruiting
Tuebingen, Germany, 72076
Contact: Ghazaleh Tabatabai, Site 0056         
Israel
Local Institution Recruiting
Petach Tikva, Israel, 49100
Contact: Site 0096         
Local Institution Recruiting
Tel Aviv, Israel, 64239
Contact: Site 0097         
Italy
Local Institution Recruiting
Bologna, Italy, 40139
Contact: Site 0076         
Local Institution Recruiting
Milano, Italy, 20133
Contact: Site 0079         
Local Institution Recruiting
Padova, Italy, 35128
Contact: Site 0126         
Local Institution Recruiting
Rozzano (milano), Italy, 20089
Contact: Site 0135         
Local Institution Recruiting
Siena, Italy, 53100
Contact: Site 0078         
Azienda Ospedaliera Citta della Salute e della Scienza Recruiting
Torino, Italy, 10126
Contact: Roberta Ruda, Site 0077         
Japan
Local Institution Recruiting
Nagoya-shi, Aichi, Japan, 4668560
Contact: Site 0115         
Local Institution Recruiting
Chiba-shi, Chiba, Japan, 2608677
Contact: Site 0125         
Local Institution Not yet recruiting
Onsen-gun, Ehime, Japan, 791-0204
Contact: Site 0124         
Local Institution Recruiting
Hiroshima-Shi, Hiroshima, Japan, 7348551
Contact: Site 0123         
Local Institution Recruiting
Sapporo-shi, Hokkaido, Japan, 0608648
Contact: Site 0122         
Local Institution Recruiting
Kobe, Hyogo, Japan, 6500017
Contact: Site 0129         
Local Institution Recruiting
Tsukuba-shi, Ibaraki, Japan, 3058576
Contact: Site 0111         
Local Institution Recruiting
Kanazawa-shi, Ishikawa, Japan, 9200934
Contact: Site 0121         
Local Institution Recruiting
Kagoshima-shi, Kagoshima, Japan, 8908520
Contact: Site 0131         
Local Institution Recruiting
Sagamihara-shi, Kanagawa, Japan, 2520375
Contact: Site 0133         
Local Institution Recruiting
Kumamoto-shi, Kumamoto, Japan, 8608556
Contact: Site 0119         
Local Institution Recruiting
Kyoto-shi, Kyoto, Japan, 606-8507
Contact: Site 0117         
Local Institution Recruiting
Kyoto-shi, Kyoto, Japan, 6128555
Contact: Site 0116         
Local Institution Recruiting
Okayama-shi, Okayama, Japan, 7008558
Contact: Site 0134         
Local Institution Recruiting
Hirakata-shi, Osaka, Japan, 5731191
Contact: Site 0120         
Local Institution Recruiting
Suita-shi, Osaka, Japan, 5650871
Contact: Site 0130         
Local Institution Recruiting
Hidaka-shi, Saitama, Japan, 3501298
Contact: Site 0113         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1138655
Contact: Site 0128         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0114         
Local Institution Recruiting
Mitaka-shi, Tokyo, Japan, 181-8611
Contact: Site 0118         
Local Institution Recruiting
Yamagata-shi, Yamagata, Japan, 9909585
Contact: Site 0110         
Local Institution Recruiting
Tokyo, Japan, 1628666
Contact: Site 0112         
Netherlands
NKI AVL Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Dieta Brandsma, Site 0045         
Universitair Medisch Centrum Groningen Active, not recruiting
Groningen, Netherlands, 9713 AP
Erasmus Mc Active, not recruiting
Rotterdam, Netherlands, 3015 CE
Universitair Medisch Centrum Utrecht Active, not recruiting
Utrecht, Netherlands, 3584 CX
Norway
Local Institution Active, not recruiting
Oslo, Norway, 0379
Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote Active, not recruiting
Gdansk, Poland, 80-952
Local Institution Not yet recruiting
Warszawa, Poland, 02-781
Contact: Site 0081         
Russian Federation
Local Institution Completed
Moscow, Russian Federation, 105229
Local Institution Not yet recruiting
Moscow, Russian Federation, 115478
Contact: Site 0105         
Local Institution Not yet recruiting
Moscow, Russian Federation, 125047
Contact: Site 0107         
Spain
Local Institution Recruiting
Badalona-Barcelona, Spain, 08916
Contact: Site 0027         
Local Institution Recruiting
Barcelona, Spain, 08035
Contact: Site 0030         
Local Institution Recruiting
Barcelona, Spain, 08036
Contact: Site 0028         
Local Institution Recruiting
Madrid, Spain, 28007
Contact: Site 0029         
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 0031         
Local Institution Recruiting
Santiago De Compostela, Spain, 15706
Contact: Site 0026         
Local Institution Recruiting
Valencia, Spain, 46014
Contact: Site 0025         
Sweden
Local Institution Completed
Lund, Sweden, 221 85
Local Institution Active, not recruiting
Stockholm, Sweden, 171 76
Switzerland
University Hospital Geneva Recruiting
Geneve, Switzerland, 1211
Contact: Pierre-Yves Dietrich, Site 0059         
Centre hospitalier universitaire Vaudois (CHUV) Recruiting
Lausanne, Switzerland, 1011
Contact: Andreas Hottinger, Site 0057         
Universitaetsspital Zuerich Recruiting
Zuerich, Switzerland, 8091
Contact: Patrick Roth, Site 0053    +41442551111      
United Kingdom
University College Hospital Active, not recruiting
London, Greater London, United Kingdom, NW1 2PG
Christie Hospital Nhs Found. Trust Active, not recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Royal Marsden Hospital Completed
Sutton, Surrey, United Kingdom, SM2 5PT
Beaston West of Scotland Cancer Centre Active, not recruiting
Glasgow, United Kingdom, G12 0YN
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02617589     History of Changes
Other Study ID Numbers: CA209-498
2015-003739-37 ( EudraCT Number )
First Submitted: November 26, 2015
First Posted: December 1, 2015
Last Update Posted: December 7, 2017
Last Verified: December 2017

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

Additional relevant MeSH terms:
Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nivolumab
Temozolomide
Dacarbazine
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action