Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	Medarex
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00289640

Purpose

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.

Condition	Intervention	Phase
Melanoma	Drug: ipilimumab (MDX-010, BMS-734016) Drug: Ipilimumab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Ipilimumab

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 Outcome Measures:

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
obtain pharmacokinetic samples for population PK analysis

Estimated Enrollment:	210
Study Start Date:	April 2006
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental	Drug: ipilimumab (MDX-010, BMS-734016) IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
2: Experimental	Drug: Ipilimumab IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
3: Experimental	Drug: Ipilimumab IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289640

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Locations

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
The Angeles Clinic And Research Institution
Santa Monica, California, United States, 90404
Wilshire Oncology Medical Group Inc
Laverne, California, United States, 91750
Scripps Cancer Center
San Diego, California, United States, 92121
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Md Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
United States, Illinois
Oncology Specialists, Sc
Park Ridge, Illinois, United States, 60068
United States, Indiana
American Health Network
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University Of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Harry And Jeanette Weinberg Cancer Inst At Franklin Square
Baltimore, Maryland, United States, 21237
United States, Minnesota
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, United States, 55422
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
St Joseph Oncology Inc
St Joseph, Missouri, United States, 64507
Washington University School Of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
United States, Ohio
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, United States, 45219
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, South Carolina
Cancer Centers Of The Carolinas
Greenville, South Carolina, United States, 29615
United States, Texas
Center For Oncology Research & Treatment, P.A.
Dallas, Texas, United States, 75230
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Australia, New South Wales
Local Institution
Newcastle, New South Wales, Australia, 2300
Australia, Queensland
Local Institution
Brisbane, Queensland, Australia, 4101
Australia, Victoria
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Wodonga, Victoria, Australia, 3690
Local Institution
Heidelberg, Victoria, Australia, 3084
Belgium
Local Institution
Bruxelles, Belgium, 1200
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Bruxelles, Belgium, 1070
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Brussels, Belgium, 1090
Brazil
Local Institution
Sao Paulo, Brazil, 01509
Brazil, Rio Grande Do Sul
Local Institution
Centro-Porto Alegre, Rio Grande Do Sul, Brazil, 90020
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90610
Brazil, Sao Paulo
Local Institution
Jau, Sao Paulo, Brazil, 17210
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Local Institution
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Local Institution
Kingston, Ontario, Canada, K7L 5P9
Czech Republic
Local Institution
Olomouc, Czech Republic, 775 20
Local Institution
Praha, Czech Republic, 128 08
France
Local Institution
Toulouse, France, 31059
Local Institution
Paris, France, 75010
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Lyon, France, 69288
Local Institution
Marseille Cedex 09, France, 13009
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Clermont Ferrand, France, 63058
Local Institution
Lyon Cedex 08, France, 69373
Local Institution
Vandoeuvre Les Nancy, France, 54511
Local Institution
Rennes, France, 35042
France, Cedex
Local Institution
Brest, Cedex, France, 29200
Germany
Local Institution
Heidelberg, Germany, 69115
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Essen, Germany, 45122
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Berlin, Germany, 12200
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Mannheim, Germany, 68169
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Wurzburg, Germany, 97080
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Jena, Germany, 07740
Local Institution
Kiel, Germany, 24105
Hungary
Local Institution
Pécs, Hungary, 7624
South Africa, Gauteng
Local Institution
Pretoria, Gauteng, South Africa, 0041
Local Institution
Pretoria, Gauteng, South Africa, 0181
Local Institution
Johannesburg, Gauteng, South Africa, 2199
South Africa, Western Cape
Local Institution
Cape Town, Western Cape, South Africa, 7506

Sponsors and Collaborators

Bristol-Myers Squibb

Medarex

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA184-022
Study First Received:	February 9, 2006
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00289640 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Stage III (unresectable)
Stage IV melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on November 27, 2009