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
16 Years
N/A
Not Enrolling
Both
Melanoma
Both
Melanoma
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 Center | Tucson, Arizona 85724 |
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
| Hubert H. Humphrey Cancer Center | Coon Rapids, Minnesota 55433 |
| Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
| Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
| Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
| Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
| Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Mary Crowley Medical Research Center | Dallas, Texas 75246 |
| Scripps Cancer Center | La Jolla, California 92037 |
| Cleveland Clinic | Cleveland, Ohio 44195 |
| Oncology Specialists, SC | Park Ridge, Illinois 60068 |
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
| University of Louisville | Louisville, Kentucky 40202 |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| Baptist Cancer Institute | Jacksonville, Florida 32207 |
| The Angeles Clinic And Research Institution | Santa Monica, California 90404 |
| St Joseph Oncology Inc | St Joseph, Missouri 64507 |
| The Christ Hospital Cancer Center Research | Cincinnati, Ohio 45219 |
| Wilshire Oncology Medical Group Inc | Laverne, California 91750 |
| American Health Network | Indianapolis, Indiana 46202 |
| Harry And Jeanette Weinberg Cancer Inst At Franklin Square | Baltimore, Maryland 21237 |
| Center For Oncology Research & Treatment, P.A. | Dallas, Texas 75230 |
