A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02714218
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

Key Dates

Start date
Apr 4, 2016
Status verified
Jun 2022
Primary completion
Apr 20, 2017
Completion
May 28, 2021

Study Design

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

Arms

  • Experimental: Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
    Specified dose on specified days
  • Experimental: Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
    Specified dose on specified days
  • Experimental: Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg
    Specified dose on specified days

Primary Outcome Measure

The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs) [ Time Frame: From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months) ]

Locations (11)

FacilityCityStateZIPSite coordinators
University Of Colorado Cancer CenterAuroraColorado80045-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
Allina HealthFridleyMinnesota55432-
Washington University School Of MedicineSt LouisMissouri63110-
Comprehensive Cancer Centers of NevadaLas VegasNevada89148-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Lehigh Valley Health NetworkAllentownPennsylvania18103-
University Of Virginia Health SystemCharlottesvilleVirginia22908-
University of Washington - Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Aurora, CO

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University Of Colorado Cancer Center· Aurora, COH. Lee Moffitt Cancer Center· Tampa, FLAllina Health· Fridley, MNWashington University School Of Medicine· St Louis, MOComprehensive Cancer Centers of Nevada· Las Vegas, NVDartmouth-Hitchcock Medical Center· Lebanon, NH

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