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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

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


Inclusion Criteria:



- Unresectable Stage III or Stage IV melanoma

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

- Brain metastases with symptoms or requiring treatment

- History of autoimmune disease

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

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Seattle Cancer Care AllianceSeattle, Washington  98109
University of California Los AngelesLos Angeles, California  90095-6951
Oncology Specialists, SCPark Ridge, Illinois  60068
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Providence Portland Medical CenterPortland, Oregon  97213-3635
Blumenthal Cancer CenterCharlotte, North Carolina  28203
Baptist Cancer InstituteJacksonville, Florida  32207
The Angeles Clinic and Research InstituteLos Angeles, California  90025
Sarah Cannon Research InstituteNashville, Tennessee  37203
New Mexico Cancer Care AllianceAlbuquerque, New Mexico  87106
Duke University HospitalDurham, North Carolina  27710
Liberty Irb, IncDeLand, Florida  32720
St. Luke'S Cancer Center - Anderson CampusEaston, Pennsylvania  18045