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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
Open (Enrolling)
Both
Melanoma

Thank you

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