Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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.
ClinicalTrials.gov Identifier: NCT02667587
Recruitment Status : Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : April 17, 2019
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

Layout table for study information
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. Progression-free survival (PFS), Blinded Independent Central Review (BICR) assessed [ Time Frame: Approximately 35 months after first patient randomized ]
  2. Overall survival (OS) defined as time from the date of randomization to the date of death. [ Time Frame: Approximately 69 months after first patient randomized ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to 24 months ]
  2. Progression free survival (PFS), investigator assessed [ Time Frame: Approximately 35 months after first patient randomized ]


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.


Layout table for eligibility information
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


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3410
United States, Arizona
St. Joseph Hospital And Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
UCLA Neuro-Oncology Program
Los Angeles, California, United States, 90095-1769
Sutter Institute For Medical Research
Sacramento, California, United States, 95816
Sharp Memorial Hospital
San Diego, California, United States, 92123
The Regents of the University of California, San Francisco
San Francisco, California, United States, 94143-0372
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
University Of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Local Institution
Chicago, Illinois, United States, 60637
United States, Kansas
University Of Kansas Medical Center
Westwood, Kansas, United States, 66205
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University School Of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
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, Missouri
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
JFK Medical Center
Edison, New Jersey, United States, 08820-3947
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Columbia University
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
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
Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
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
Erlanger Oncology & Hematology - Univ. of TN
Chattanooga, Tennessee, United States, 37403
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
University Of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Australia, New South Wales
Local Institution
Liverpool, New South Wales, Australia, 2017
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Australia, Victoria
Local Institution
Heidelberg, Victoria, Australia, 3084
Local Institution
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Austria
Kepler Universitaetsklinikum
Linz, Austria, 4020
Medical University Of Vienna
Vienna, Austria, 1090
Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Uz Leuven
Leuven, Belgium, 3000
Canada, British Columbia
BC Cancer - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A 2B4
Denmark
Local Institution
Copenhagen, Denmark, 2100
Local Institution
Odense, Denmark, 5000
France
Local Institution
Lille Cedex, France, 59037
Local Institution
Lyon Cedex 03, France, 69394
Local Institution
Marseille, France, 13385
Local Institution
Nancy, France, 54035
Local Institution
Paris cedex 13, France, 75651
Local Institution
Paris, France, 75010
Local Institution
Rennes Cedex, France, 35042
Local Institution
Toulouse, France, 31100
Germany
Universitaetsklinikum Bonn
Bonn, Germany, 53105
Uniklinik Erlangen
Erlangen, Germany, 91054
Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main
Frankfurt Am Main, Germany, 60528
Universitaetsklinikum Freiburg
Freiburg, Germany, 79106
Universitaetsklinikum Hamburg
Hamburg, Germany, 20246
Universitaetsklinik Heidelberg
Heidelberg, Germany, 69120
Universitaetsklinik Koeln
Koeln, Germany, 50937
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Klinikum rechts der Isar der Technischen Universitat Munchen
Munich, Germany, 81675
Bezirksklinikum Regensburg
Regensburg, Germany, 93053
Universitasklinikum Tubingen
Tuebingen, Germany, 72076
Israel
Local Institution
Petach Tikva, Israel, 49100
Local Institution
Tel Aviv, Israel, 64239
Italy
Local Institution
Bologna, Italy, 40139
Local Institution
Milano, Italy, 20133
Local Institution
Padova, Italy, 35128
Local Institution
Rozzano (milano), Italy, 20089
Local Institution
Siena, Italy, 53100
Azienda Ospedaliera Citta della Salute e della Scienza
Torino, Italy, 10126
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4668560
Local Institution
Chiba-shi, Chiba, Japan, 2600856
Local Institution
Hiroshima-Shi, Hiroshima, Japan, 7348551
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Kobe-shi, Hyogo, Japan, 650-0017
Local Institution
Tsukuba-shi, Ibaraki, Japan, 3058576
Local Institution
Kanazawa-shi, Ishikawa, Japan, 9200934
Local Institution
Kagoshima-shi, Kagoshima, Japan, 8908520
Local Institution
Sagamihara-shi, Kanagawa, Japan, 2520375
Local Institution
Kumamoto-shi, Kumamoto, Japan, 8608556
Local Institution
Kyoto-shi, Kyoto, Japan, 6128555
Local Institution
Okayama-shi, Okayama, Japan, 7008558
Local Institution
Hirakata-shi, Osaka, Japan, 5731191
Local Institution
Suita-shi, Osaka, Japan, 5650871
Local Institution
Hidaka-shi, Saitama, Japan, 3501298
Local Institution
Bunkyo-ku, Tokyo, Japan, 1138655
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Local Institution
Mitaka-shi, Tokyo, Japan, 181-8611
Local Institution
Shinjuku-ku, Tokyo, Japan, 1628666
Local Institution
Yamagata-shi, Yamagata, Japan, 9909585
Local Institution
Kyoto, Japan, 6068507
Netherlands
NKI AVL
Amsterdam, Netherlands, 1066 CX
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 AP
Erasmus Mc
Rotterdam, Netherlands, 3015 CE
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Norway
Local Institution
Oslo, Norway, 0424
Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote
Gdansk, Poland, 80-952
Klinika Nowotworow Glowy i Szyi
Warszawa, Poland, 02-781
Russian Federation
Local Institution
Moscow, Russian Federation, 105229
Local Institution
Moscow, Russian Federation, 115478
Spain
Local Institution
Badalona-barcelona, Spain, 08916
Local Institution
Barcelona, Spain, 08035
Local Institution
Barcelona, Spain, 08036
Local Institution
Madrid, Spain, 28009
Local Institution
Madrid, Spain, 28041
Local Institution
Santiago Compostela, Spain, 15706
Local Institution
Valencia, Spain, 46014
Sweden
Local Institution
Lund, Sweden, 221 85
Local Institution
Solna, Sweden, 171 64
Switzerland
University Hospital Geneva
Geneve, Switzerland, 1211
Centre hospitalier universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
UniversitaetsSpital Zurich
Zuerich, Switzerland, 8091
United Kingdom
University College Hospital
London, Greater London, United Kingdom, NW1 2PG
Christie Hospital Nhs Found. Trust
Manchester, Greater Manchester, United Kingdom, M20 4BX
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Beaston West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal 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: April 17, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for 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
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action