A Single Arm Study of Ipilimumab 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:	NCT00289627

Purpose

The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) 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:

Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.

Secondary Outcome Measures:

estimate disease control rate
estimate progression free survival rate at Week 12
estimate PFS
estimate overall survival
estimate survival rate at one year
estimate duration of BOR
evaluate proportion of patients whose duration of response is >=24 weeks
estimate time to BOR
evaluate safety profile of ipilimumab during the induction and maintenance phases
evaluate health-related quality of life
obtain PK sample for population PK analysis

Estimated Enrollment:	150
Study Start Date:	March 2006
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental	Drug: ipilimumab (MDX-010, BMS-734016) 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:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with previously treated Stage III (unresectable)or Stage IV melanoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289627

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Locations

United States, Arkansas
Local Institution
Little Rock, Arkansas, United States
United States, California
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Long Beach, California, United States
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Newport Beach, California, United States
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Santa Monica, California, United States
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San Francisco, California, United States
United States, Illinois
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Chicago, Illinois, United States
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Park Ridge, Illinois, United States
United States, Indiana
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Goshen, Indiana, United States
United States, Kentucky
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Hazard, Kentucky, United States
United States, Maryland
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Baltimore, Maryland, United States
United States, Nevada
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Las Vegas, Nevada, United States
United States, New Mexico
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Albuquerque, New Mexico, United States
United States, New York
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New York, New York, United States
United States, Oregon
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Portland, Oregon, United States
United States, South Carolina
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Greenville, South Carolina, United States
United States, Tennessee
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Knoxville, Tennessee, United States
United States, Texas
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Dallas, Texas, United States
United States, Virginia
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Charlottesville, Virginia, United States
Austria
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Wien, Austria
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Salzburg, Austria
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Wels, Austria
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Wien, Austria
Finland
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Turku, Finland
Italy
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Padova, Italy
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Genova, Italy
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Napoli, Italy
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Forli, Italy
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Torino, Italy
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Siena, Italy
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Milano, Italy
Norway
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Oslo, Norway
Poland
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Wroclaw, Poland
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Poznan, Poland
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Bielsko-Biala, Poland
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Lodz, Poland
Russian Federation
Lcoal Institution
St. Petersburg, Russian Federation
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Stavropol, Russian Federation
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Samara, Russian Federation
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Rayazan, Russian Federation
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Moscow, Russian Federation
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Velikiy Novgorod, Russian Federation
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Murmansk, Russian Federation
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Ekaterinburg, Russian Federation
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Voronezh, Russian Federation
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Moscow, Russian Federation
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Barnaul, Russian Federation
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St. Petersburg, Russian Federation
Spain
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Zaragoza, Spain
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Madrid, Spain
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Barcelona, Spain
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Valencia, Spain
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Valencia, Spain
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Tenerife, Spain
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Malaga, Spain
Sweden
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Uppsala, Sweden
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Goteborg, Sweden
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Lund, Sweden
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Stockholm, Sweden
Ukraine
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Dnepropetrovsk, Ukraine
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Kiev, Ukraine
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Cherkassy, Ukraine
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Sumy, Ukraine
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Lviv, Ukraine
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Uzhgorod, Ukraine

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 by Bristol-Myers Squibb

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Di Giacomo AM, Danielli R, Guidoboni M, Calabrò L, Carlucci D, Miracco C, Volterrani L, Mazzei MA, Biagioli M, Altomonte M, Maio M. Therapeutic efficacy of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with metastatic melanoma unresponsive to prior systemic treatments: clinical and immunological evidence from three patient cases. Cancer Immunol Immunother. 2009 Aug;58(8):1297-306. Epub 2009 Jan 13.

Study ID Numbers:	CA184-008
Study First Received:	February 9, 2006
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00289627 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Previously treated melanoma
Unresectable Stage III
Stage IV

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 25, 2009