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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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 |
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Recruitment Status :
Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : September 11, 2020
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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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 |
|---|---|
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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
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Drug: Nivolumab
Other Names:
Drug: Temozolomide Other Names:
Radiation: Radiotherapy Other Name: RT |
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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
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Drug: Temozolomide
Other Names:
Radiation: Radiotherapy Other Name: RT Other: Nivolumab Placebo |
Primary Outcome Measures :
- Progression-free survival (PFS), Blinded Independent Central Review (BICR) assessed [ Time Frame: Approximately 35 months after first patient randomized ]
- 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 :
- Overall Survival (OS) [ Time Frame: up to 24 months ]
- Progression free survival (PFS), investigator assessed [ Time Frame: Approximately 35 months after first patient randomized ]
Information from the National Library of Medicine
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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
Locations
Hide 123 study locations
| 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 Medical Center | |
| 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-Siteman Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| JFK Medical Center | |
| Edison, New Jersey, United States, 08820 | |
| 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, 75390-8852 | |
| 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, 2170 | |
| 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 | |
| Hopital Neurologique Pierre Wertheimer | |
| Lyon Cedex 03, France, 69394 | |
| Local Institution | |
| Marseille, France, 13385 | |
| Local Institution | |
| Nancy, France, 54035 | |
| Groupe Hospitalier Pitie-Salpetriere | |
| Paris cedex 13, France, 75651 | |
| Hopital Saint Louis | |
| Paris, France, 75010 | |
| Centre Eugene Marquis | |
| Rennes Cedex, France, 35042 | |
| Institut Univ Cancer Toulouse | |
| Toulouse, France, 31100 | |
| Germany | |
| Universitaetsklinikum Bonn | |
| Bonn, Germany, 53127 | |
| 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 | |
| Universitaetsklinikum Koeln | |
| Koeln, Germany, 50937 | |
| Universitaetsklinikum Muenster | |
| Muenster, Germany, 48149 | |
| Klinikum rechts der Isar der Technischen Universitat Munchen | |
| Munich, Germany, 81675 | |
| Universitaetsklinikum 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 | |
| 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 | |
| Local Institution | |
| Tsukuba-shi, Japan, 3058576 | |
| 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, 80-214 | |
| 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
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02667587 |
| Other Study ID Numbers: |
CA209-548 2015-004722-34 ( EudraCT Number ) |
| First Posted: | January 29, 2016 Key Record Dates |
| Last Update Posted: | September 11, 2020 |
| Last Verified: | September 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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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 Antineoplastic Agents, Immunological Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |