Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01515189
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 determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg

Key Dates

Start date
Feb 17, 2012
Status verified
Jul 2019
Primary completion
Feb 6, 2016
Completion
Aug 17, 2017

Study Design

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

Arms

  • Experimental: Arm 1: Ipilimumab (3 mg/kg)
    Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
  • Experimental: Arm 2: Ipilimumab (10 mg/kg)
    Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Approximately 48 months (assessed up to February 2016) ]

Locations (11)

FacilityCityStateZIPSite coordinators
The Angeles Clinic And Research InstituteLos AngelesCalifornia90025-
University Of California Los AngelesLos AngelesCalifornia90095-
Baptist Cancer InstituteJacksonvilleFlorida32207-
Orlando Health, IncOrlandoFlorida32806-
Oncology Specialists, S.C.Park RidgeIllinois60068-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke University HospitalDurhamNorth Carolina27710-
Providence Portland Medical CenterPortlandOregon97213-
St. Luke's Cancer Center - Anderson CampusEastonPennsylvania18045-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
The Angeles Clinic And Research Institute· Los Angeles, CAUniversity Of California Los Angeles· Los Angeles, CABaptist Cancer Institute· Jacksonville, FLOrlando Health, Inc· Orlando, FLOncology Specialists, S.C.· Park Ridge, ILMemorial Sloan Kettering Cancer Center· New York, NY

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