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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)

This study is currently recruiting participants.
Verified November 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02667587
First Posted: January 29, 2016
Last Update Posted: November 17, 2017
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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
January 26, 2016
January 29, 2016
November 17, 2017
May 5, 2016
May 29, 2019   (Final data collection date for primary outcome measure)
Overall survival (OS) defined as time from the date of randomization to the date of death. [ Time Frame: Approximately 69 months after first patient first visit ]
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 ]
Complete list of historical versions of study NCT02667587 on ClinicalTrials.gov Archive Site
  • Progression free survival (PFS), defined as the time from randomization to the date of the first documented tumor progression or death to any cause. [ Time Frame: Approximately 69 months after first patient first visit ]
  • Correlation of PFS and OS [ Time Frame: Approximately 69 months after first patient first visit ]
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 ]
Not Provided
Not Provided
 
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)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Brain Neoplasms
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
693
January 8, 2022
May 29, 2019   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Israel,   Italy,   Japan,   Netherlands,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
 
 
NCT02667587
CA209-548
2015-004722-34 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2017

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