An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02596035
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.

Key Dates

Start date
Jan 8, 2016
Status verified
Oct 2022
Primary completion
Mar 19, 2018
Completion
May 24, 2021

Study Design

Enrollment
197 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Nivolumab
    Nivolumab dose as specified

Primary Outcome Measure

Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) [ Time Frame: Up to 100 days of the last dose of study drug (Approximately 2 years) ]

Locations (39)

FacilityCityStateZIPSite coordinators
Local Institution - 0030PhoenixArizona85016-
Comprehensive Blood And Cancer CenterBakersfieldCalifornia93309-
St. Jude Hospital Yorba LindaFullertonCalifornia92835-
Cancer Care Associates Medical Group, Inc.Redondo BeachCalifornia90277-
Sansum Santa Barbara Medical Foundation ClinicSanta BarbaraCalifornia93105-
University Of ColoradoAuroraColorado80045-
Local Institution - 0028Grand JunctionColorado81501-
Local Institution - 0018LakewoodColorado80228-
Local Institution - 0008Fort MyersFlorida33901-
Baptist Health Medical Group OncologyMiamiFlorida33176-
Local Institution - 0007St. PetersburgFlorida33705-
Local Institution - 0054TampaFlorida33612-9497-
Illinois Cancer SpecialistsNilesIllinois60714-
Local Institution - 0052Fort WayneIndiana46845-
Norton Cancer InstituteLouisvilleKentucky40202-
Sidney Kimmel Comprehensive Cancer Center At Johns HopkinsBaltimoreMaryland21231-
HCA Midwest DivisionKansas CityMissouri64132-
Southeast Nebraska Hematology & Oncology Consultants, P.C.LincolnNebraska68510-
Local Institution - 0011OmahaNebraska68130-
Urology Cancer Center LaboratoryOmahaNebraska68130-
Local Institution - 0014Las VegasNevada89169-
Local Institution - 0053BuffaloNew York14263-
Broome OncologyJohnson CityNew York13790-
Local Institution - 0055New YorkNew York10065-
Local Institution - 0001TulsaOklahoma74146-
Local Institution - 0016PortlandOregon97213-2982-
Local Institution - 0020CharlestonSouth Carolina29414-
Local Institution - 0005ChattanoogaTennessee37404-
Local Institution - 0012GermantownTennessee38138-
Local Institution - 0004NashvilleTennessee37203-
Local Institution - 0015DallasTexas75246-
The Center For Cancer And Blood DisordersFort WorthTexas76104-
Local Institution - 0034HoustonTexas77024-
Local Institution - 0021San AntonioTexas78217-
Texas Cancer Center - ShermanShermanTexas75090-0504-
Local Institution - 0032NorfolkVirginia23502-
Local Institution - 0047RichmondVirginia23230-
Local Institution - 0017RoanokeVirginia24014-
Local Institution - 0039SeattleWashington98109-

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By research site
Local Institution - 0030· Phoenix, AZComprehensive Blood And Cancer Center· Bakersfield, CASt. Jude Hospital Yorba Linda· Fullerton, CACancer Care Associates Medical Group, Inc.· Redondo Beach, CASansum Santa Barbara Medical Foundation Clinic· Santa Barbara, CAUniversity Of Colorado· Aurora, CO

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