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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02617589
Registration number
NCT02617589
Ethics application status
Date submitted
26/11/2015
Date registered
1/12/2015
Date last updated
28/03/2023
Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
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Scientific title
A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)
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Secondary ID [1]
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2015-003739-37
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Secondary ID [2]
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CA209-498
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 498
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain Cancer
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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
Experimental: Nivolumab + Radiotherapy Arm - Nivolumab IV infusion + Radiotherapy dose as specified
Active comparator: Temozolomide + Radiotherapy Arm - Temozolomide + Radiotherapy dose as specified
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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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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.
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Timepoint [1]
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up to 3 years
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Secondary outcome [1]
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Kaplan-Meier Plot of Progression Free Survival
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Assessment method [1]
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PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
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Timepoint [1]
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From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)
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Secondary outcome [2]
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Overall Survival Rate at 24 Months
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Assessment method [2]
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The overall survival (OS) rate of (nivolumab + radiation therapy) and (temozolomide + radiation therapy) estimated as Kaplan-Meier probability of survival at 24 months. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
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Timepoint [2]
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At 24 Months
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Secondary outcome [3]
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Overall Survival in Tumor Mutational Burden (TMB) High Population
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Assessment method [3]
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OS in all randomized participants that are tumor mutational burden high. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
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Timepoint [3]
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From randomization to the date of death due to any cause (up to approximately 6 years)
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Secondary outcome [4]
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Progression Free Survival in Tumor Mutational Burden (TMB) High Population
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Assessment method [4]
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PFS in all randomized participants that are tumor mutational burden high. PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
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Timepoint [4]
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From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)
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Eligibility
Key inclusion criteria
* Males and Females, age = 18 years old
* Newly-diagnosed brain cancer or tumor called glioblastoma or GBM
* Tumor test result shows MGMT unmethylated type
* Karnofsky performance status of = 70 (able to care for self)
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Minimum age
18
Years
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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
* 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
* Biopsy with less than 20% of tumor removed
Other protocol-defined inclusion/exclusion criteria 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/03/2022
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Sample size
Target
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Accrual to date
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Final
560
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Royal North Shore Hospital - St. Leonards
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Local Institution - 0003 - Heidelberg
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Local Institution - 0002 - New South Wales
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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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2170 - New South Wales
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Other collaborator category [1]
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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-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.
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Trial website
https://clinicaltrials.gov/study/NCT02617589
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Trial related presentations / publications
Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.
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Public notes
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/89/NCT02617589/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/89/NCT02617589/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02617589
Download to PDF