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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)
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)
Secondary ID [1] 0 0
2015-003739-37
Secondary ID [2] 0 0
CA209-498
Universal Trial Number (UTN)
Trial acronym
CheckMate 498
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional(has expanded access)
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
up to 3 years
Secondary outcome [1] 0 0
Kaplan-Meier Plot of Progression Free Survival
Timepoint [1] 0 0
From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)
Secondary outcome [2] 0 0
Overall Survival Rate at 24 Months
Timepoint [2] 0 0
At 24 Months
Secondary outcome [3] 0 0
Overall Survival in Tumor Mutational Burden (TMB) High Population
Timepoint [3] 0 0
From randomization to the date of death due to any cause (up to approximately 6 years)
Secondary outcome [4] 0 0
Progression Free Survival in Tumor Mutational Burden (TMB) High Population
Timepoint [4] 0 0
From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/03/2022
Sample size
Target
Accrual to date
Final
560
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
Local Institution - 0003 - Heidelberg
Recruitment hospital [3] 0 0
Local Institution - 0004 - Prahran
Recruitment hospital [4] 0 0
Local Institution - 0001 - Nedlands
Recruitment hospital [5] 0 0
Local Institution - 0002 - New South Wales
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3181 - Prahran
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2170 - New South Wales
Recruitment outside Australia
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Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02617589
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02617589