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

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