A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS)

Outcome Description:

OS is defined for each subject as the time between randomization date and death. If a subject has not died, the subject will be censored at the time of last contact (last known alive date) OS will be assessed after 540 death events have occurred. Interim analysis after 360 deaths have occurred

Outcome Time Frame:

Approximately 44 months after the first subject is randomized

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-169

NCT ID:

NCT01515189

Start Date:

January 2012

Completion Date:

December 2016

Related Keywords:

• Melanoma
• Melanoma