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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02667587
Registration number
NCT02667587
Ethics application status
Date submitted
26/01/2016
Date registered
29/01/2016
Date last updated
29/05/2024
Titles & IDs
Public title
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)
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Scientific 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
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Secondary ID [1]
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2015-004722-34
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Secondary ID [2]
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CA209-548
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Universal Trial Number (UTN)
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Trial acronym
CheckMate548
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain Neoplasms
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Condition category
Condition code
Cancer
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Brain
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Temozolomide
Treatment: Other - Radiotherapy
Other interventions - Nivolumab Placebo
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
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
Treatment: Drugs: Nivolumab
Treatment: Drugs: Temozolomide
Treatment: Other: Radiotherapy
Other interventions: Nivolumab Placebo
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Intervention code [1]
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Treatment: Drugs
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) Determined by BICR
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Assessment method [1]
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The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.
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Timepoint [1]
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From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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The time from the date of randomization to the date of death. who have not died by the end of the study will be censored to last known date alive. OS is assessed in the randomized population with no corticosteroids at baseline population and in the overall randomized population.
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Timepoint [2]
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From randomization to date of death (up to approximately 4.5 years)
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Secondary outcome [1]
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Overall Survival (OS) Rates at 12 Months
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Assessment method [1]
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Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months
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Timepoint [1]
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From randomization to 12 months after first dose
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Secondary outcome [2]
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Overall Survival (OS) Rates at 24 Months
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Assessment method [2]
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Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months
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Timepoint [2]
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From randomization to 24 months after first dose
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Secondary outcome [3]
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Progression Free Survival (PFS) Based on Investigator Assessment
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Assessment method [3]
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The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by investigator assessment based Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.
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Timepoint [3]
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From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
- 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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Phase
Phase 3
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Recruitment
Recruitment status
Completed
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Data analysis
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/05/2016
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Actual
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Anticipated
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Actual
9/04/2024
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Sample size
Target
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Accrual to date
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Final
716
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Recruitment in Australia
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NSW,VIC,WA
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Local Institution - 0049 - Liverpool
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2170 - Liverpool
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2065 - St. Leonards
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3084 - Heidelberg
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3181 - Prahran
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
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Name
Bristol-Myers Squibb
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Ono Pharmaceutical Co. Ltd
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02667587
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02667587
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