Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01696045
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab

Key Dates

Start date
Nov 12, 2012
Status verified
Jul 2017
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016

Study Design

Enrollment
14 participants (actual)
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab 3 mg/kg
    Ipilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
  • Experimental: Ipilimumab 10 mg/kg
    Ipilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.

Primary Outcome Measure

Overall Survival (OS) Rate at 1 Year [ Time Frame: 1 year following start of treatment (Assessed up to June 2016, approximately 38 months) ]

Locations (14)

FacilityCityStateZIPSite coordinators
Phoenix Children'S HospitalPhoenixArizona85016-
Childrens Hospital Of LaLos AngelesCalifornia90027-
Children'S Hospital Of Orange CountyOrangeCalifornia92868-
Children'S Hospital ColoradoAuroraColorado80045-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
James Whitcomb Riley Hospital For ChildrenIndianapolisIndiana46202-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Mayo ClinicRochesterMinnesota55905-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University Of Pittsburgh Medical Center Cancer CenterPittsburghPennsylvania15232-
St. Jude Children'S Research HospitalMemphisTennessee38105-
The University Of Texas Md Anderson Cancer CenterHoustonTexas77030-
Primary Children'S Medical CenterSalt Lake CityUtah84113-
University Of UtahSalt Lake CityUtah84113-

Find similar trials in Phoenix, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Phoenix Children'S Hospital· Phoenix, AZChildrens Hospital Of La· Los Angeles, CAChildren'S Hospital Of Orange County· Orange, CAChildren'S Hospital Colorado· Aurora, COH. Lee Moffitt Cancer Center & Research Institute· Tampa, FLJames Whitcomb Riley Hospital For Children· Indianapolis, IN

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