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 :
Active, not recruiting
First Posted : January 29, 2016
Results First Posted : February 3, 2022
Last Update Posted : December 27, 2022
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Tracking Information | |||||
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First Submitted Date ICMJE | January 26, 2016 | ||||
First Posted Date ICMJE | January 29, 2016 | ||||
Results First Submitted Date ICMJE | November 30, 2021 | ||||
Results First Posted Date ICMJE | February 3, 2022 | ||||
Last Update Posted Date | December 27, 2022 | ||||
Actual Study Start Date ICMJE | May 9, 2016 | ||||
Actual Primary Completion Date | December 22, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Overall survival defined as time from the date of randomization to the date of death. [ Time Frame: Approximately 54 months after first patient first visit ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Progression free survival, defined as the time from randomization to the date of the first documented tumor progression or death to any cause. [ Time Frame: Approximately 54 months after first patient first visit ] | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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) | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Brain Neoplasms | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
716 | ||||
Original Estimated Enrollment ICMJE |
320 | ||||
Estimated Study Completion Date ICMJE | August 1, 2023 | ||||
Actual Primary Completion Date | December 22, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02667587 | ||||
Other Study ID Numbers ICMJE | CA209-548 2015-004722-34 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Bristol-Myers Squibb | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Ono Pharmaceutical Co. Ltd | ||||
Investigators ICMJE |
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PRS Account | Bristol-Myers Squibb | ||||
Verification Date | December 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |