A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Melanoma
Both
Melanoma
Trial Information
A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.
Inclusion Criteria:
- Diagnosis of advanced melanoma
- Prior treatment in a prior/parent ipilimumab study
- Men and women >=18 years of age (or, >=16, if allowable per local regulatory
authority)
Exclusion Criteria:
- Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist, except for
ipilimumab
- Primary ocular or mucosal melanoma
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To monitor safety of ipilimumab by evaluating the frequency of adverse events and laboratory abnormalities with corresponding severity.
Outcome Time Frame:
throughout the study
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:
CA184-025
NCT ID:
NCT00162123
Start Date:
May 2006
Completion Date:
September 2014
Related Keywords:
- Melanoma
- ipilimumab
- previously treated
- Melanoma
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| University of Washington Medical Center | Seattle, Washington 98195-6043 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
| University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
| Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
| Scripps Cancer Center | La Jolla, California 92037 |
| Comprehensive Cancer Center | Glendale, California 91204 |
| Oncology Specialists, SC | Park Ridge, Illinois 60068 |
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
| University of Chicago | Chicago, Illinois 60637 |
| Baptist Cancer Institute | Jacksonville, Florida 32207 |
| San Francisco Oncology Associates | San Francisco, California 94115 |
| The Angeles Clinic & Research Inst. | Los Angeles, California 90025 |
| Orlando Health, Inc. M.D. Anderson Cancer Center Orlando | Orlando, Florida 32806 |
| St. Francis Medical Group Oncology And Hematology Specialist | Indianapolis, Indiana 46237 |
| Harry & Jeanette Weinberg Cancer Inst At Franklin Square | Baltimore, Maryland 21237 |
| St Joseph Oncology Inc | St Joseph, Missouri 64507 |
| Presbyterian Hospital Cancer Research | Charlotte, North Carolina 28204 |
| The Christ Hospital Cancer Center Research | Cincinnati, Ohio 45219 |
