An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02617589
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
  • Temozolomide — DRUG
  • Radiotherapy — RADIATION

Study Details

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

Key Dates

Start date
Mar 1, 2016
Status verified
Mar 2023
Primary completion
Jan 17, 2019
Completion
Mar 4, 2022

Study Design

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

Arms

  • Experimental: Nivolumab + Radiotherapy Arm
    Nivolumab IV infusion + Radiotherapy dose as specified
  • Active Comparator: Temozolomide + Radiotherapy Arm
    Temozolomide + Radiotherapy dose as specified

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: up to 3 years ]

Locations (37)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-3410-
Local Institution - 0083PhoenixArizona85013-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Local Institution - 0019Los AngelesCalifornia90095-1769-
Sutter Institute For Medical ResearchSacramentoCalifornia95816-
Sharp Memorial HospitalSan DiegoCalifornia92123-
The Regents of the University of California, San FranciscoSan FranciscoCalifornia94143-0372-
Yale Cancer CenterNew HavenConnecticut06520-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
University Of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Moffitt Cancer CenterTampaFlorida33612-
Emory University - Winship Cancer InstituteAtlantaGeorgia30322-
The University Of ChicagoChicagoIllinois60637-
University Of Kansas Medical CenterWestwoodKansas66205-
Norton Cancer InstituteLouisvilleKentucky40202-
Johns Hopkins University School Of MedicineBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02215-
Local Institution - 0006DetroitMichigan48202-
Washington University School OF Medicine-Siteman Cancer CenterSt LouisMissouri63110-
JFK Medical CenterEdisonNew Jersey08820-
Local Institution - 0064HackensackNew Jersey07601-
Columbia University Medical Center (Cumc)New YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Preston Robert Tisch Brain Tumor Center at Duke UniversityDurhamNorth Carolina27710-
Local Institution - 0010ClevelandOhio44195-
Local Institution - 0095ColumbusOhio43210-
Local Institution - 0132AllentownPennsylvania18103-
Local Institution - 0007PhiladelphiaPennsylvania19107-
Medical University Of South CarolinaCharlestonSouth Carolina29425-
Local Institution - 0090ChattanoogaTennessee37404-
Vanderbilt University Medical CenterNashvilleTennessee37232-
University Of Texas Southwestern Medical CenterDallasTexas75390-8852-
University Of Texas Md Anderson Cancer CtrHoustonTexas77030-
Local Institution - 0068Salt Lake CityUtah84112-
Swedish Neuroscience InstituteSeattleWashington98122-

Find similar trials in Birmingham, AL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Alabama at Birmingham· Birmingham, ALLocal Institution - 0083· Phoenix, AZCedars Sinai Medical Center· Los Angeles, CALocal Institution - 0019· Los Angeles, CASutter Institute For Medical Research· Sacramento, CASharp Memorial Hospital· San Diego, CA

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