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A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma


Phase 2
16 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma


Inclusion Criteria:



- Patients with previously treated, therapy-refractory or -intolerant, Stage III
(unresectable) or Stage IV melanoma

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.

Authority:

United States: Food and Drug Administration

Study ID:

CA184-022

NCT ID:

NCT00289640

Start Date:

April 2006

Completion Date:

July 2007

Related Keywords:

  • Melanoma
  • Stage III (unresectable)
  • Stage IV melanoma
  • Melanoma

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Hubert H. Humphrey Cancer CenterCoon Rapids, Minnesota  55433
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Mary Crowley Medical Research CenterDallas, Texas  75246
Scripps Cancer CenterLa Jolla, California  92037
Cleveland ClinicCleveland, Ohio  44195
Oncology Specialists, SCPark Ridge, Illinois  60068
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of LouisvilleLouisville, Kentucky  40202
Yale University School Of MedicineNew Haven, Connecticut  06520
Baptist Cancer InstituteJacksonville, Florida  32207
The Angeles Clinic And Research InstitutionSanta Monica, California  90404
St Joseph Oncology IncSt Joseph, Missouri  64507
The Christ Hospital Cancer Center ResearchCincinnati, Ohio  45219
Wilshire Oncology Medical Group IncLaverne, California  91750
American Health NetworkIndianapolis, Indiana  46202
Harry And Jeanette Weinberg Cancer Inst At Franklin SquareBaltimore, Maryland  21237
Center For Oncology Research & Treatment, P.A.Dallas, Texas  75230