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)

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT02667587
• Date of registration: 26/01/2016
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• 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) CheckMate548
• 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
• Date of first enrolment: May 9, 2016
• Target sample size: 716
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02667587
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- 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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Brain Neoplasms

Intervention(s)

Radiation: Radiotherapy

Other: Nivolumab Placebo

Drug: Nivolumab

Drug: Temozolomide

Primary Outcome(s)

Progression-free Survival (PFS) Determined by BICR [Time Frame: From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)]

Overall Survival (OS) [Time Frame: From randomization to date of death (up to approximately 4.5 years)]

Secondary Outcome(s)

Overall Survival (OS) Rates at 12 Months [Time Frame: From randomization to 12 months after first dose]

Overall Survival (OS) Rates at 24 Months [Time Frame: From randomization to 24 months after first dose]

Progression Free Survival (PFS) Based on Investigator Assessment [Time Frame: From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)]

Secondary ID(s)

2015-004722-34

CA209-548

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ono Pharmaceutical Co. Ltd

Results

• Results available: Yes
• Date Posted: 03/02/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02667587