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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 CenterTucson, Arizona  85724
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Washington University School of MedicineSaint Louis, Missouri  63110
University of Washington Medical CenterSeattle, Washington  98195-6043
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Scripps Cancer CenterLa Jolla, California  92037
Comprehensive Cancer CenterGlendale, California  91204
Oncology Specialists, SCPark Ridge, Illinois  60068
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of ChicagoChicago, Illinois  60637
Baptist Cancer InstituteJacksonville, Florida  32207
San Francisco Oncology AssociatesSan Francisco, California  94115
The Angeles Clinic & Research Inst.Los Angeles, California  90025
Orlando Health, Inc. M.D. Anderson Cancer Center OrlandoOrlando, Florida  32806
St. Francis Medical Group Oncology And Hematology SpecialistIndianapolis, Indiana  46237
Harry & Jeanette Weinberg Cancer Inst At Franklin SquareBaltimore, Maryland  21237
St Joseph Oncology IncSt Joseph, Missouri  64507
Presbyterian Hospital Cancer ResearchCharlotte, North Carolina  28204
The Christ Hospital Cancer Center ResearchCincinnati, Ohio  45219