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An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (CheckMate548)

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ClinicalTrials.gov Identifier: NCT02667587
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving Nivolumab in addition to temozolomide plus radiation therapy.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Drug: Nivolumab Drug: Temozolomide Radiation: Radiotherapy Other: Nivolumab Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 693 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma
Actual Study Start Date : May 5, 2016
Estimated Primary Completion Date : February 11, 2022
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: Nivolumab + Temozolomide + Radiotherapy
Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
Drug: Nivolumab
Other Names:
  • Opdivo
  • Nivo
  • N
  • BMS-936558

Drug: Temozolomide
Other Names:
  • Temodar
  • TMZ
  • Temodal
  • Temcad

Radiation: Radiotherapy
Other Name: RT

Placebo Comparator: Nivolumab placebo + Temozolomide + Radiotherapy
Nivolumab Placebo: specified dose on specified days; IV infusion Temozolomide: 75 mg/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units 5x/week x 6 weeks
Drug: Temozolomide
Other Names:
  • Temodar
  • TMZ
  • Temodal
  • Temcad

Radiation: Radiotherapy
Other Name: RT

Other: Nivolumab Placebo



Primary Outcome Measures :
  1. Overall survival (OS) defined as time from the date of randomization to the date of death. [ Time Frame: Approximately 69 months after first patient first visit ]

Secondary Outcome Measures :
  1. Progression free survival (PFS), defined as the time from randomization to the date of the first documented tumor progression or death to any cause. [ Time Frame: Approximately 69 months after first patient first visit ]
  2. Correlation of PFS and OS [ Time Frame: Approximately 69 months after first patient first visit ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb 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
  • Karnofsky performance status of ≥ 70 (able to take care of self)
  • Substantial recovery from surgery resection
  • Tumor test result shows MGMT methylated or indeterminate tumor subtype

Exclusion Criteria:

  • Biopsy-only of GBM with less than 20% of tumor removed
  • 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

Other protocol defined inclusion/exclusion criteria could apply


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): NCT02667587


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 Active, not recruiting
Los Angeles, California, United States, 90048
UCLA Neuro-Oncology Program Active, not recruiting
Los Angeles, California, United States, 90095-1769
Sutter Institute For Medical Research Completed
Sacramento, California, United States, 95816
Sharp Memorial Hospital Active, not recruiting
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 University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Joachim Baehring, Site 0004    203-785-7486      
United States, District of Columbia
Georgetown University Active, not recruiting
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, Illinois
Local Institution Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Site 0022         
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, 21287
United States, Massachusetts
Dana-Farber Cancer Institute Active, not recruiting
Boston, Massachusetts, United States, 02215
Local Institution Withdrawn
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital Active, not recruiting
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
Columbia University Active, not recruiting
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mariza Daras, Site 0024    212-610-0239      
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 Completed
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University Wexner Medical Center Active, not recruiting
Columbus, Ohio, United States, 43210
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 Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
University Of Texas Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75390
Local Institution Withdrawn
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 Active, not recruiting
Liverpool, New South Wales, Australia, 2017
Royal North Shore Hospital Active, not recruiting
St. Leonards, New South Wales, Australia, 2065
Australia, Victoria
Local Institution Active, not recruiting
Heidelberg, Victoria, Australia, 3084
Local Institution Active, not recruiting
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Sir Charles Gairdner Hospital Active, not recruiting
Nedlands, Western Australia, Australia, 6009
Austria
Kepler Universitaetsklinikum Active, not recruiting
Linz, Austria, 4020
Medical University Of Vienna Active, not recruiting
Vienna, Austria, 1090
Belgium
Universitair Ziekenhuis Brussel Recruiting
Brussels, Belgium, 1090
Contact: Bart Neyns, Site 0070    +3224775457      
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Nicolas Whenham, Site 0069    +3210437147      
Uz Leuven Recruiting
Leuven, Belgium, 3000
Contact: Paul Clement, Site 0071    +3216346903      
Canada, British Columbia
BC Cancer - Vancouver Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Cancer Centre Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal Neurological Institute and Hospital Active, not recruiting
Montreal, Quebec, Canada, H3A 2B4
Denmark
Local Institution Active, not recruiting
Copenhagen, Denmark, 2100
Local Institution Active, not recruiting
Odense, Denmark, 5000
France
Local Institution Active, not recruiting
Lille Cedex, France, 59037
Local Institution Active, not recruiting
Lyon Cedex 03, France, 69394
Local Institution Active, not recruiting
Marseille, France, 13385
Local Institution Active, not recruiting
Nancy, France, 54035
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
Germany
Universitaetsklinikum Bonn Active, not recruiting
Bonn, Germany, 53105
Uniklinik Erlangen Active, not recruiting
Erlangen, Germany, 91054
Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main Active, not recruiting
Frankfurt Am Main, Germany, 60528
Universitaetsklinikum Freiburg Active, not recruiting
Freiburg, Germany, 79106
Universitaetsklinikum Hamburg Active, not recruiting
Hamburg, Germany, 20246
Universitaetsklinik Heidelberg Active, not recruiting
Heidelberg, Germany, 69120
Universitaetsklinik Koeln Active, not recruiting
Koeln, Germany, 50937
Universitaetsklinikum Muenster Active, not recruiting
Muenster, Germany, 48149
Klinikum rechts der Isar der Technischen Universitat Munchen Completed
Munich, Germany, 81675
Bezirksklinikum Regensburg Active, not recruiting
Regensburg, Germany, 93053
Universitasklinikum Tubingen Active, not recruiting
Tuebingen, Germany, 72076
Israel
Local Institution Active, not recruiting
Petach Tikva, Israel, 49100
Local Institution Active, not recruiting
Tel Aviv, Israel, 64239
Italy
Local Institution Active, not recruiting
Bologna, Italy, 40139
Local Institution Active, not recruiting
Milano, Italy, 20133
Local Institution Active, not recruiting
Padova, Italy, 35128
Local Institution Active, not recruiting
Rozzano (milano), Italy, 20089
Local Institution Active, not recruiting
Siena, Italy, 53100
Local Institution Active, not recruiting
Torino, Italy, 10126
Japan
Local Institution Active, not recruiting
Nagoya-shi, Aichi, Japan, 4668560
Local Institution Active, not recruiting
Chiba-shi, Chiba, Japan, 2600856
Local Institution Active, not recruiting
Hiroshima-Shi, Hiroshima, Japan, 7348551
Local Institution Active, not recruiting
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution Active, not recruiting
Kobe-shi, Hyogo, Japan, 650-0017
Local Institution Active, not recruiting
Tsukuba-shi, Ibaraki, Japan, 3058576
Local Institution Active, not recruiting
Kanazawa-shi, Ishikawa, Japan, 9200934
Local Institution Active, not recruiting
Kagoshima-shi, Kagoshima, Japan, 8908520
Local Institution Active, not recruiting
Sagamihara-shi, Kanagawa, Japan, 2520375
Local Institution Active, not recruiting
Kumamoto-shi, Kumamoto, Japan, 8608556
Local Institution Active, not recruiting
Kyoto-shi, Kyoto, Japan, 6128555
Local Institution Active, not recruiting
Okayama-shi, Okayama, Japan, 7000914
Local Institution Active, not recruiting
Hirakata-shi, Osaka, Japan, 5731191
Local Institution Active, not recruiting
Suita-shi, Osaka, Japan, 5650871
Local Institution Active, not recruiting
Hidaka-shi, Saitama, Japan, 3501298
Local Institution Active, not recruiting
Bunkyo-ku, Tokyo, Japan, 1138655
Local Institution Active, not recruiting
Chuo-ku, Tokyo, Japan, 1040045
Local Institution Active, not recruiting
Mitaka-shi, Tokyo, Japan, 181-8611
Local Institution Active, not recruiting
Shinjuku-ku, Tokyo, Japan, 1628666
Local Institution Completed
Yamagata-shi, Yamagata, Japan, 9909585
Local Institution Active, not recruiting
Kyoto, Japan, 6068507
Netherlands
NKI AVL Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Dieta Brandsma, Site 0075    +31205122570      
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9713 AP
Contact: Annemiek Walenkamp, Site 0074    +31503616161      
Erasmus Mc Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Martin Van Den Bent, Site 0073    +31107041415      
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Filip De Vos, Site 0072    +31887556263      
Norway
Local Institution Active, not recruiting
Oslo, Norway, 0424
Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote Active, not recruiting
Gdansk, Poland, 80-952
Klinika Nowotworow Glowy i Szyi Active, not recruiting
Warszawa, Poland, 02-781
Russian Federation
Local Institution Active, not recruiting
Moscow, Russian Federation, 105229
Local Institution Active, not recruiting
Moscow, Russian Federation, 115478
Local Institution Withdrawn
Moscow, Russian Federation, 125047
Spain
Local Institution Active, not recruiting
Badalona-barcelona, Spain, 08916
Local Institution Active, not recruiting
Barcelona, Spain, 08035
Local Institution Active, not recruiting
Barcelona, Spain, 08036
Local Institution Active, not recruiting
Madrid, Spain, 28009
Local Institution Active, not recruiting
Madrid, Spain, 28041
Local Institution Active, not recruiting
Santiago Compostela, Spain, 15706
Local Institution Active, not recruiting
Valencia, Spain, 46014
Sweden
Local Institution Active, not recruiting
Lund, Sweden, 221 85
Local Institution Active, not recruiting
Solna, Sweden, 171 64
Switzerland
University Hospital Geneva Active, not recruiting
Geneve, Switzerland, 1211
Centre hospitalier universitaire Vaudois (CHUV) Active, not recruiting
Lausanne, Switzerland, 1011
UniversitaetsSpital Zurich Active, not recruiting
Zuerich, Switzerland, 8091
United Kingdom
University College Hospital Recruiting
London, Greater London, United Kingdom, NW1 2PG
Contact: Paul Mulholland, Site 0067    +444473809358      
Christie Hospital Nhs Found. Trust Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Catherine Mcbain, Site 0066    +441614463000      
Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Liam Welsh, Site 0119         
Beaston West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Stefan Nowicki, Site 0068    +441413017000      
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02667587     History of Changes
Other Study ID Numbers: CA209-548
2015-004722-34 ( EudraCT Number )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

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

Additional relevant MeSH terms:
Glioblastoma
Nivolumab
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
Temozolomide
Dacarbazine
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action