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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02667587




Registration number
NCT02667587
Ethics application status
Date submitted
26/01/2016
Date registered
29/01/2016
Date last updated
15/07/2019

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)
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
Secondary ID [1] 0 0
2015-004722-34
Secondary ID [2] 0 0
CA209-548
Universal Trial Number (UTN)
Trial acronym
CheckMate548
Linked study record

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

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS), Blinded Independent Central Review (BICR) assessed
Timepoint [1] 0 0
Approximately 35 months after first patient randomized
Primary outcome [2] 0 0
Overall survival (OS) defined as time from the date of randomization to the date of death.
Timepoint [2] 0 0
Approximately 69 months after first patient randomized
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
up to 24 months
Secondary outcome [2] 0 0
Progression free survival (PFS), investigator assessed
Timepoint [2] 0 0
Approximately 35 months after first patient randomized

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

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Liverpool
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [3] 0 0
Local Institution - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - Prahran
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2017 - Liverpool
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3181 - Prahran
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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New York
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Texas
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Utah
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Washington
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Linz
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Vienna
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Brussels
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Koeln
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Greater Manchester
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Surrey
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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-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.
Trial website
https://clinicaltrials.gov/show/NCT02667587
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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02667587