Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
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
1 other identifier
interventional
210
10 countries
62
Brief Summary
The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) 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. The safety of this product will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2006
Shorter than P25 for phase_2
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2006
CompletedFirst Posted
Study publicly available on registry
February 10, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedMarch 2, 2010
January 1, 2009
1.2 years
February 9, 2006
February 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (6)
estimate progression free survival rate at Week 12 assessment and other timepoints
estimate disease control rate at various time points
estimate overall survival
estimate survival rate at one year
evaluate health-related quality of life
- +1 more secondary outcomes
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTALInterventions
IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Eligibility Criteria
You may qualify if:
- Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Medarexcollaborator
Study Sites (62)
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Wilshire Oncology Medical Group Inc
Laverne, California, 91750, United States
Scripps Cancer Center
San Diego, California, 92121, United States
The Angeles Clinic And Research Institution
Santa Monica, California, 90404, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Oncology Specialists, Sc
Park Ridge, Illinois, 60068, United States
American Health Network
Indianapolis, Indiana, 46202, United States
University Of Louisville
Louisville, Kentucky, 40202, United States
Harry And Jeanette Weinberg Cancer Inst At Franklin Square
Baltimore, Maryland, 21237, United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422, United States
Ellis Fischel Cancer Center
Columbia, Missouri, 65203, United States
St Joseph Oncology Inc
Saint Joseph, Missouri, 64507, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Cancer Centers Of The Carolinas
Greenville, South Carolina, 29615, United States
Center For Oncology Research & Treatment, P.A.
Dallas, Texas, 75230, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
Local Institution
Newcastle, New South Wales, 2300, Australia
Local Institution
Brisbane, Queensland, 4101, Australia
Local Institution
Heidelberg, Victoria, 3084, Australia
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Wodonga, Victoria, 3690, Australia
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Brussels, 1070, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Centro-Porto Alegre, Rio Grande do Sul, 90020, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 90610, Brazil
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Jaú, São Paulo, 17210, Brazil
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São Paulo, São Paulo, 01509, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Kingston, Ontario, K7L 5P9, Canada
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Olomouc, 775 20, Czechia
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Prague, 128 08, Czechia
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Brest, Cedex, 29200, France
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Clermont-Ferrand, 63058, France
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Lyon, 69288, France
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Lyon, 69373, France
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Marseille, 13009, France
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Paris, 75010, France
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Rennes, 35042, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Berlin, 12200, Germany
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Essen, 45122, Germany
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Heidelberg, 69115, Germany
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Jena, 07740, Germany
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Kiel, 24105, Germany
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Mannheim, 68169, Germany
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Würzburg, 97080, Germany
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Pécs, 7624, Hungary
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Johannesburg, Gauteng, 2199, South Africa
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Pretoria, Gauteng, 0041, South Africa
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Pretoria, Gauteng, 0181, South Africa
Local Institution
Cape Town, Western Cape, 7506, South Africa
Related Publications (2)
Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
PMID: 25667295DERIVEDWolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbe C. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010 Feb;11(2):155-64. doi: 10.1016/S1470-2045(09)70334-1. Epub 2009 Dec 8.
PMID: 20004617DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 9, 2006
First Posted
February 10, 2006
Study Start
April 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
March 2, 2010
Record last verified: 2009-01