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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02667587
Phase
PHASE3
Status
Completed

Conditions

  • Brain Neoplasms

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
May 9, 2016
Status verified
Jun 2025
Primary completion
Dec 22, 2020
Completion
Apr 9, 2024

Study Design

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

Arms

  • 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
  • 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

Primary Outcome Measure

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) ]

Locations (35)

FacilityCityStateZIPSite coordinators
Local Institution - 0023BirminghamAlabama35294-3410-
Local Institution - 0003PhoenixArizona85013-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Local Institution - 0010Los AngelesCalifornia90095-1769-
Local Institution - 0128SacramentoCalifornia95816-
Local Institution - 0029San DiegoCalifornia92123-
Local Institution - 0006San FranciscoCalifornia94143-0372-
Local Institution - 0004New HavenConnecticut06520-
Local Institution - 0031Washington D.C.District of Columbia20007-
Local Institution - 0087MiamiFlorida33136-
Local Institution - 0030TampaFlorida33612-
Local Institution - 0022ChicagoIllinois60637-
Local Institution - 0060WestwoodKansas66205-
Local Institution - 0018LouisvilleKentucky40202-
Local Institution - 0020BaltimoreMaryland21287-
Local Institution - 0011BostonMassachusetts02215-
Local Institution - 0028BostonMassachusetts02215-
Local Institution - 0035DetroitMichigan48202-
Local Institution - 0002St LouisMissouri63110-
Local Institution - 0017EdisonNew Jersey08820-
Local Institution - 0012HackensackNew Jersey07601-
Local Institution - 0015New YorkNew York10032-
Local Institution - 0024New YorkNew York10065-
Local Institution - 0032CharlotteNorth Carolina28204-
Preston Robert Tisch Brain Tumor Center at Duke UniversityDurhamNorth Carolina27710-
Local Institution - 0001ClevelandOhio44195-
Local Institution - 0027ColumbusOhio43210-
Local Institution - 0098AllentownPennsylvania18103-
Local Institution - 0016PhiladelphiaPennsylvania19107-
Local Institution - 0021CharlestonSouth Carolina29425-
Erlanger Oncology & Hematology - Univ. of TNChattanoogaTennessee37403-
Local Institution - 0008NashvilleTennessee37232-
Local Institution - 0025DallasTexas75390-8575-
Local Institution - 0009Salt Lake CityUtah84112-
Local Institution - 0005SeattleWashington98122-

Find similar trials in Birmingham, AL

By research site
Local Institution - 0023· Birmingham, ALLocal Institution - 0003· Phoenix, AZCedars Sinai Medical Center· Los Angeles, CALocal Institution - 0010· Los Angeles, CALocal Institution - 0128· Sacramento, CALocal Institution - 0029· San Diego, CA

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