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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)

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ClinicalTrials.gov Identifier: NCT02667587
Recruitment Status : Active, not recruiting
First Posted : January 29, 2016
Results First Posted : February 3, 2022
Last Update Posted : December 27, 2022
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 26, 2016
First Posted Date  ICMJE January 29, 2016
Results First Submitted Date  ICMJE November 30, 2021
Results First Posted Date  ICMJE February 3, 2022
Last Update Posted Date December 27, 2022
Actual Study Start Date  ICMJE May 9, 2016
Actual Primary Completion Date December 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2022)
  • 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) ]
    The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.
  • Overall Survival (OS) [ Time Frame: From randomization to date of death (up to approximately 4.5 years) ]
    The time from the date of randomization to the date of death. who have not died by the end of the study will be censored to last known date alive. OS is assessed in the randomized population with no corticosteroids at baseline population and in the overall randomized population.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
Overall survival defined as time from the date of randomization to the date of death. [ Time Frame: Approximately 54 months after first patient first visit ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2022)
  • Overall Survival (OS) Rates at 12 Months [ Time Frame: From randomization to 12 months after first dose ]
    Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months
  • Overall Survival (OS) Rates at 24 Months [ Time Frame: From randomization to 24 months after first dose ]
    Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months
  • 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) ]
    The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by investigator assessment based Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
Progression free survival, defined as the time from randomization to the date of the first documented tumor progression or death to any cause. [ Time Frame: Approximately 54 months after first patient first visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Brain Neoplasms
Intervention  ICMJE
  • Drug: Nivolumab
    Other Names:
    • Opdivo
    • Nivo
    • N
    • BMS-936558
  • Drug: Temozolomide
    Other Names:
    • Temodar
    • TMZ
    • Temodal
    • Temcad
  • Radiation: Radiotherapy
    Other Name: RT
  • Other: Nivolumab Placebo
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Nivolumab
    • Drug: Temozolomide
    • Radiation: Radiotherapy
  • 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
    Interventions:
    • Drug: Temozolomide
    • Radiation: Radiotherapy
    • Other: Nivolumab Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 18, 2021)
716
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2016)
320
Estimated Study Completion Date  ICMJE August 1, 2023
Actual Primary Completion Date December 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Israel,   Italy,   Japan,   Netherlands,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02667587
Other Study ID Numbers  ICMJE CA209-548
2015-004722-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP