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


Phase 2
12 Years
17 Years
Open (Enrolling)
Both
Malignant Melanoma

Thank you

Trial Information

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


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:



- 12 < 18 years of age

- Previously treated or untreated, unresectable Stage III or Stage IV malignant
melanoma

- Karnofsky Performance Status (KPS) or Lansky Score ≥ 50

Exclusion Criteria:

- Primary Ocular Melanoma

- Prior therapy with a Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) or Programmed death- 1
(PD-1) antagonist, or Programmed cell death- ligand 1 (PD-L1) or CD137 agonists

- Symptomatic brain metastases

- History of autoimmune diseases

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival Rate at 1-Year

Outcome Description:

Overall Survival Rate at 1-Year is defined as the probability that a subject is alive at one year following start of treatment. The time frame for this endpoint is from Day 1 of first patient first treatment to Day 365 from the last patient first treatment

Outcome Time Frame:

Up to 1 year after last patient first treatment (LPFT)

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-178

NCT ID:

NCT01696045

Start Date:

April 2013

Completion Date:

July 2017

Related Keywords:

  • Malignant Melanoma
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Mayo ClinicRochester, Minnesota  55905
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Children's Hospital of Orange CountyOrange, California  92668
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Local InstitutionBaltimore, Maryland  
Local InstitutionAustin, Texas  
Children's Hospital ColoradoAurora, Colorado  80045
Childrens hospital of LALos Angeles, California  90033