A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02017717
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    specified dose on specified days
  • Bevacizumab — BIOLOGICAL
    specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    specified dose on specified days

Study Details

The purpose of the study is to compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of GBM therapy.

Key Dates

Start date
Feb 7, 2014
Status verified
Mar 2025
Primary completion
Jun 17, 2019
Completion
Jun 21, 2024

Study Design

Enrollment
529 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm N:Nivolumab
    Cohort 1, 1c, 1d and 2: Nivolumab specified dose on specified days
  • Experimental: Arm N + I:Nivolumab + Ipilimumab
    Cohort 1: Nivolumab specified dose on specified days + Ipilimumab specified dose on specified days, then Nivolumab specified dose on specified days Cohort 1b: Nivolumab specified dose on specified days + Ipilimumab specified dose on specified days, then Nivolumab specified dose on specified days
  • Active Comparator: Arm B: Bevacizumab
    Cohort 2: Bevacizumab specified dose on specified days

Primary Outcome Measure

Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses [ Time Frame: Includes events reported between first dose and 30 days after last dose of study therapy (up to 3 doses, up to approximately 2 months) ]

Locations (46)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-3410-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Local Institution - 0009Los AngelesCalifornia90095-1769-
Local Institution - 0055Los AngelesCalifornia90048-
UCLA Neuro-Oncology ProgramLos AngelesCalifornia90095-1769-
Local Institution - 0014San FranciscoCalifornia94143-0372-
The Regents of the University of California, San FranciscoSan FranciscoCalifornia94143-0372-
Anschutz Cancer PavilionAuroraColorado80045-
Local Institution - 0021AuroraColorado80045-
Local Institution - 0001New HavenConnecticut06520-
Yale University School Of MedicineNew HavenConnecticut06520-
Georgetown UniversityWashington D.C.District of Columbia20007-
Moffitt Cancer CenterTampaFlorida33612-
Local Institution - 0002AtlantaGeorgia30322-
Winship Cancer InstituteAtlantaGeorgia30322-
Johns Hopkins University School Of MedicineBaltimoreMaryland21287-
Local Institution - 0008BaltimoreMaryland21287-
Beth Israel Deaconess Med CtrBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Local Institution - 0006BostonMassachusetts02215-
Local Institution - 0043BostonMassachusetts02215-
Local Institution - 0056BostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02215-
Henry Ford Health SystemDetroitMichigan48202-2608-
Henry Ford Health SystemDetroitMichigan48202-
Mayo ClinicRochesterMinnesota55905-
Local Institution - 0003New YorkNew York10065-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Local Institution - 0007DurhamNorth Carolina27710-
Preston Robert Tisch Brain Tumor Center at Duke UniversityDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Local Institution - 0049ClevelandOhio44106-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Thomas Jefferson University - Clinical Research InstitutePhiladelphiaPennsylvania19107-
Local Institution - 0023CharlestonSouth Carolina29425-
Medical University Of South CarolinaCharlestonSouth Carolina29425-
Local Institution - 0005NashvilleTennessee37232-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Local Institution - 0024HoustonTexas77030-4009-
University Of Texas Md Anderson Cancer CtrHoustonTexas77030-4009-
University Of Virginia Health SystemCharlottesvilleVirginia22908-
Local Institution - 0020SeattleWashington98122-
Swedish Neuroscience InstituteSeattleWashington98122-
University of Washington - Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Birmingham, AL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Alabama at Birmingham· Birmingham, ALCedars Sinai Medical Center· Los Angeles, CALocal Institution - 0009· Los Angeles, CALocal Institution - 0055· Los Angeles, CAUCLA Neuro-Oncology Program· Los Angeles, CALocal Institution - 0014· San Francisco, CA

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