A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02713867
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

Key Dates

Start date
May 24, 2016
Status verified
Jan 2023
Primary completion
Jul 15, 2019
Completion
Jan 18, 2022

Study Design

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

Arms

  • Active Comparator: Nivolumab 240 mg
    Nivolumab 240 mg Every 2 Weeks
  • Experimental: Nivolumab 480 mg
    Nivolumab 480 mg Every 4 Weeks

Primary Outcome Measure

Progression Free Survival Rate (PFSR) at 6 Months [ Time Frame: At 6 Months ]

Locations (77)

FacilityCityStateZIPSite coordinators
Local Institution - 0004BirminghamAlabama35205-
Local Institution - 0030PhoenixArizona85016-
Local Institution - 0041PhoenixArizona85016-
CBCC Global Research, Inc.BakersfieldCalifornia93309-
Southern California Permanente Medical GroupBellflowerCalifornia90706-
St Jude Hospital Yorba LindaFullertonCalifornia92835-
Local Institution - 0046Los AngelesCalifornia90095-
Local Institution - 0126OrangeCalifornia92868-
Torrance Health AssociationRedondo BeachCalifornia90227-
Sharp Memorial HospitalSan DiegoCalifornia92123-
Local Institution - 0010Santa BarbaraCalifornia93015-
Local Institution - 0044Santa MariaCalifornia93454-
Local Institution - 0130VallejoCalifornia94589-
Local Institution - 0017DenverColorado80218-1210-
Local Institution - 0122Fort CollinsColorado80528-
Local Institution - 0038Fort MyersFlorida33901-
Local Institution - 0089HollywoodFlorida33021-
Local Institution - 0026OcalaFlorida34471-
Local Institution - 0001PensacolaFlorida32504-
Local Institution - 0039St. PetersburgFlorida33705-
Local Institution - 0008AthensGeorgia30607-
Local Institution - 0142ColumbusGeorgia31904-
Local Institution - 0121MariettaGeorgia30060-
Ingalls Health SystemHarveyIllinois60426-
Local Institution - 0098NilesIllinois60714-
Local Institution - 0100PeoriaIllinois61615-
Local Institution - 0143UrbanaIllinois61801-2594-
Local Institution - 0050Fort WayneIndiana46804-
Local Institution - 0099Fort WayneIndiana46485-
Innova Schar Cancer InstituteIndianapolisIndiana46237-
Local Institution - 0123WichitaKansas67214-
Local Institution - 0112PaducahKentucky42003-
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-
Local Institution - 0137New OrleansLouisiana70121-
Local Institution - 0109BrewerMaine04412-
Local Institution - 0042BethesdaMaryland20817-
Local Institution - 0125SpringfieldMassachusetts01107-
Local Institution - 0136SouthfieldMichigan48075-
Local Institution - 0120MinneapolisMinnesota55404-
Local Institution - 0116TupeloMississippi38801-
Mercy Medical Research InstituteSpringfieldMissouri65806-
Local Institution - 0014OmahaNebraska68130-
Local Institution - 0141LebanonNew Hampshire03756-
Local Institution - 0035AlbanyNew York12206-
Local Institution - 0013Johnson CityNew York13790-
Local Institution - 0127PinehurstNorth Carolina28374-
Hematology And Oncology AssociatesCantonOhio44708-
Local Institution - 0037CincinnatiOhio45242-
Local Institution - 0132CincinnatiOhio45242-
MetroHealth Cancer Care CenterClevelandOhio44109-
Local Institution - 0129MassillonOhio44646-
Hematology Oncology Consultants, PcMedfordOregon97504-
Local Institution - 0005PittsburghPennsylvania15224-
Local Institution - 0020CharlestonSouth Carolina29414-
Local Institution - 0124Sioux FallsSouth Dakota57105-
Jones Clinic PCGermantownTennessee38138-
Local Institution - 0036NashvilleTennessee37203-
Local Institution - 0023AbileneTexas79606-5208-
Texas Oncology - AmarilloAmarilloTexas79106-
Local Institution - 0011DallasTexas75230-
Local Institution - 0022DallasTexas75231-
Texas Oncology, P.A.DentonTexas76210-
Texas Oncology, P.A.El PasoTexas79902-
Local Institution - 0025Flower MoundTexas75028-
Texas Oncology, P.A.HoustonTexas77024-
Texas Oncology, P.A.LongviewTexas75601-
Local Institution - 0119MidlandTexas79701-
Texas Oncology, P.A.PlanoTexas75093-
Texas Oncology, P.A.San AntonioTexas78212-
Texas Oncology, P.A.ShermanTexas75090-
Texas Oncology, P.A.Sugar LandTexas77479-
Local Institution - 0034Wichita FallsTexas76310-
Innova Schar Cancer InstituteFalls ChurchVirginia22042-
Shenandoah OncologyWinchesterVirginia22601-
Cancer Care NorthwestSpokane ValleyWashington99216-
Local Institution - 0031VancouverWashington98684-
Yakima Valley Memorial Hospital/North Star LodgeYakimaWashington98902-

Find similar trials in Birmingham, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Local Institution - 0004· Birmingham, ALLocal Institution - 0030· Phoenix, AZLocal Institution - 0041· Phoenix, AZCBCC Global Research, Inc.· Bakersfield, CASouthern California Permanente Medical Group· Bellflower, CASt Jude Hospital Yorba Linda· Fullerton, CA

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