A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162123

Purpose

The purpose of this study is to evaluate the continued use of ipilimumab in patients who had clinical benefit in a prior/parent study and are now eligible to receive either Re-Induction at the time of disease progression or to continue Maintenance treatment. In addition, this study will also continue to follow patients that have had ipilimumab but who are not eligible for Maintenance or Re-Induction therapy.

Condition	Intervention	Phase
Melanoma	Drug: Ipilimumab	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	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.

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:

To monitor safety of ipilimumab by evaluating the frequency of adverse events and laboratory abnormalities with corresponding severity. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Estimate overall survival from the first dose [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Estimate survival rate from the first dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Monitor Immune Breakthrough Events [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	207
Study Start Date:	May 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Ipilimumab Intravenous Solution, Intravenous, 3 or 10 mg/kg, One dose every 3 weeks or every 3 months, until patient discontinuation from any study Phase or withdrawal of consent
B: Experimental	Drug: Ipilimumab Intravenous Solution, Intravenous, 0.3, 3 or 10 mg/kg, One Dose every 3 weeks or every 3 months, until patient discontinuation from any study Phase or withdrawal of consent or no intervention
C: No Intervention Until withdrawal of consent or study closure

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162123

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Locations

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
The Angeles Clinic & Research Inst.
Los Angeles, California, United States, 90025
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
San Francisco Oncology Associates
San Francisco, California, United States, 94115
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States, 46237
United States, Missouri
St Joseph Oncology Inc
St Joseph, Missouri, United States, 64507
Washington University School Of Medicine
St. Louis, Missouri, United States, 63110
United States, New Mexico
University Of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, United States, 45219
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Washington
University Of Washington Medical Center
Seattle, Washington, United States, 98109
Australia, New South Wales
Local Institution
Newcastle, New South Wales, Australia, 2300
Austria
Local Institution
Salzburg, Austria, A-5020
Local Institution
Wien, Austria, 1090
Local Institution
Wien, Austria, 1160
Belgium
Local Institution
Brussels, Belgium, 1090
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Brussels, Belgium, 1070
Brazil, Rio Grande Do Sul
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90050
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Local Institution
Moncton, New Brunswick, Canada, E1C 6Z8
Czech Republic
Local Institution
Olomouc, Czech Republic, 775 20
Local Institution
Praha 2, Czech Republic, 128 08
Denmark
Local Institution
Aarhus C, Denmark, 8000
France
Local Institution
Vandoeuvre Les Nancy, France, 54511
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Paris, France, 75010
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Lyon Cedex 08, France, 69373
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Marseille, France, 13009
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Pierre Benite, France, 69495
France, Cedex 1
Local Institution
Clermont Ferrand, Cedex 1, France, 63058
Germany
Local Institution
Heidelberg, Germany, D-69115
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Kiel, Germany, D-24105
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Mannheim, Germany, 68167
Israel
Local Institution
Tel Aviv, Israel, 64239
Local Institution
Jerusalem, Israel, 91120
Italy
Local Institution
Siena, Italy, 53100
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Meldola (Fc), Italy, 47014
Local Institution
Genova, Italy, 16132
Norway
Local Institution
Oslo, Norway, 0310
Peru
Local Institution
Lima, Peru, 41
Local Institution
Lima, Peru, 41
Poland
Local Institution
Wroclaw, Poland, 51-124
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Poznan, Poland, 61-866
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Lodz, Poland, 90553
Russian Federation
Local Institution
Stavropol, Russian Federation, 355047
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Voronezh, Russian Federation, 394000
Local Institution
St. Petersburg, Russian Federation, 191104
South Africa, Gauteng
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
Spain
Local Institution
Valencia, Spain, 46009
Ukraine
Local Institution
Dnepropetrovsk, Ukraine, 49044

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

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

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://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:	CA184-025
Study First Received:	September 9, 2005
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00162123 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

ipilimumab
previously treated

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