Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Nivolumab
Treatment: Drugs - Temozolomide
Treatment: Other - Radiotherapy

Experimental: Nivolumab + Radiotherapy Arm - Nivolumab IV infusion + Radiotherapy dose as specified

Active Comparator: Temozolomide + Radiotherapy Arm - Temozolomide + Radiotherapy dose as specified


Treatment: Drugs: Nivolumab


Treatment: Drugs: Temozolomide


Treatment: Other: Radiotherapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Austria
State/province [25] 0 0
Linz
Country [26] 0 0
Austria
State/province [26] 0 0
Vienna
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Bruxelles
Country [29] 0 0
Belgium
State/province [29] 0 0
Leuven
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Denmark
State/province [33] 0 0
Copenhagen
Country [34] 0 0
Denmark
State/province [34] 0 0
Odense
Country [35] 0 0
France
State/province [35] 0 0
Bron Cedex
Country [36] 0 0
France
State/province [36] 0 0
Lille Cedex
Country [37] 0 0
France
State/province [37] 0 0
Marseille
Country [38] 0 0
France
State/province [38] 0 0
Nancy
Country [39] 0 0
France
State/province [39] 0 0
Paris cedex 13
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
France
State/province [41] 0 0
Rennes
Country [42] 0 0
France
State/province [42] 0 0
Toulouse
Country [43] 0 0
Germany
State/province [43] 0 0
Bonn
Country [44] 0 0
Germany
State/province [44] 0 0
Erlangen
Country [45] 0 0
Germany
State/province [45] 0 0
Frankfurt am Main
Country [46] 0 0
Germany
State/province [46] 0 0
Freiburg
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Germany
State/province [48] 0 0
Heidelberg
Country [49] 0 0
Germany
State/province [49] 0 0
Koeln
Country [50] 0 0
Germany
State/province [50] 0 0
Muenster
Country [51] 0 0
Germany
State/province [51] 0 0
Munich
Country [52] 0 0
Germany
State/province [52] 0 0
Regensburg
Country [53] 0 0
Germany
State/province [53] 0 0
Tuebingen
Country [54] 0 0
Israel
State/province [54] 0 0
Petach Tikva
Country [55] 0 0
Israel
State/province [55] 0 0
Tel Aviv
Country [56] 0 0
Italy
State/province [56] 0 0
Bologna
Country [57] 0 0
Italy
State/province [57] 0 0
Milano
Country [58] 0 0
Italy
State/province [58] 0 0
Padova
Country [59] 0 0
Italy
State/province [59] 0 0
Rozzano (milano)
Country [60] 0 0
Italy
State/province [60] 0 0
Siena
Country [61] 0 0
Italy
State/province [61] 0 0
Torino
Country [62] 0 0
Japan
State/province [62] 0 0
Aichi
Country [63] 0 0
Japan
State/province [63] 0 0
Chiba
Country [64] 0 0
Japan
State/province [64] 0 0
Hiroshima
Country [65] 0 0
Japan
State/province [65] 0 0
Hokkaido
Country [66] 0 0
Japan
State/province [66] 0 0
Hyogo
Country [67] 0 0
Japan
State/province [67] 0 0
Ibaraki
Country [68] 0 0
Japan
State/province [68] 0 0
Ishikawa
Country [69] 0 0
Japan
State/province [69] 0 0
Kagoshima
Country [70] 0 0
Japan
State/province [70] 0 0
Kanagawa
Country [71] 0 0
Japan
State/province [71] 0 0
Kumamoto
Country [72] 0 0
Japan
State/province [72] 0 0
Kyoto
Country [73] 0 0
Japan
State/province [73] 0 0
Okayama
Country [74] 0 0
Japan
State/province [74] 0 0
Osaka
Country [75] 0 0
Japan
State/province [75] 0 0
Saitama
Country [76] 0 0
Japan
State/province [76] 0 0
Tokyo
Country [77] 0 0
Japan
State/province [77] 0 0
Yamagata
Country [78] 0 0
Netherlands
State/province [78] 0 0
Amsterdam
Country [79] 0 0
Netherlands
State/province [79] 0 0
Groningen
Country [80] 0 0
Netherlands
State/province [80] 0 0
Rotterdam
Country [81] 0 0
Netherlands
State/province [81] 0 0
Utrecht
Country [82] 0 0
Norway
State/province [82] 0 0
Oslo
Country [83] 0 0
Poland
State/province [83] 0 0
Gdansk
Country [84] 0 0
Poland
State/province [84] 0 0
Warszawa
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Moscow
Country [86] 0 0
Spain
State/province [86] 0 0
Badalona-Barcelona
Country [87] 0 0
Spain
State/province [87] 0 0
Barcelona
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Santiago De Compostela
Country [90] 0 0
Spain
State/province [90] 0 0
Valencia
Country [91] 0 0
Sweden
State/province [91] 0 0
Lund
Country [92] 0 0
Sweden
State/province [92] 0 0
Solna
Country [93] 0 0
Switzerland
State/province [93] 0 0
Geneve
Country [94] 0 0
Switzerland
State/province [94] 0 0
Lausanne
Country [95] 0 0
Switzerland
State/province [95] 0 0
Zuerich
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Greater London
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Greater Manchester
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Surrey
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Glasgow

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/ct2/show/NCT02617589
Trial related presentations / publications
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