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NCT00289640 Clinical Trial

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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00289640
Other study ID # CA184-022
Secondary ID
Status Completed
Phase Phase 2
First received February 9, 2006
Last updated February 27, 2010
Start date April 2006
Est. completion date July 2007

Study information
Verified date January 2009
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
• Ipilimumab
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
• Ipilimumab
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.

Locations
Country Name City State
Australia Local Institution Brisbane Queensland
Australia Local Institution Heidelberg Victoria
Australia Local Institution Newcastle New South Wales
Australia Local Institution Wodonga Victoria
Belgium Local Institution Brussels
Belgium Local Institution Bruxelles
Belgium Local Institution Bruxelles
Brazil Local Institution Centro-Porto Alegre Rio Grande Do Sul
Brazil Local Institution Jau Sao Paulo
Brazil Local Institution Porto Alegre Rio Grande Do Sul
Brazil Local Institution Sao Paulo
Canada Local Institution Calgary Alberta
Canada Local Institution Edmonton Alberta
Canada Local Institution Kingston Ontario
Czech Republic Local Institution Olomouc
Czech Republic Local Institution Praha
France Local Institution Brest Cedex
France Local Institution Clermont Ferrand
France Local Institution Lyon
France Local Institution Lyon Cedex 08
France Local Institution Marseille Cedex 09
France Local Institution Paris
France Local Institution Rennes
France Local Institution Toulouse
France Local Institution Vandoeuvre Les Nancy
Germany Local Institution Berlin
Germany Local Institution Essen
Germany Local Institution Heidelberg
Germany Local Institution Jena
Germany Local Institution Kiel
Germany Local Institution Mannheim
Germany Local Institution Wurzburg
Hungary Local Institution Pécs
South Africa Local Institution Cape Town Western Cape
South Africa Local Institution Johannesburg Gauteng
South Africa Local Institution Pretoria Gauteng
South Africa Local Institution Pretoria Gauteng
United States Harry And Jeanette Weinberg Cancer Inst At Franklin Square Baltimore Maryland
United States Presbyterian Hospital Charlotte North Carolina
United States The Christ Hospital Cancer Center Research Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States Ellis Fischel Cancer Center Columbia Missouri
United States Center For Oncology Research & Treatment, P.A. Dallas Texas
United States Mary Crowley Medical Research Center Dallas Texas
United States Cancer Centers Of The Carolinas Greenville South Carolina
United States American Health Network Indianapolis Indiana
United States Baptist Cancer Institute Jacksonville Florida
United States Wilshire Oncology Medical Group Inc Laverne California
United States University Of Louisville Louisville Kentucky
United States Mount Sinai Comprehensive Cancer Center Miami Beach Florida
United States Yale University School Of Medicine New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York
United States Md Anderson Cancer Center Orlando Orlando Florida
United States Oncology Specialists, Sc Park Ridge Illinois
United States Providence Portland Medical Center Portland Oregon
United States Hubert H. Humphrey Cancer Center Robbinsdale Minnesota
United States Scripps Cancer Center San Diego California
United States The Angeles Clinic And Research Institution Santa Monica California
United States St Joseph Oncology Inc St Joseph Missouri
United States Washington University School Of Medicine St. Louis Missouri
United States Arizona Cancer Center Tucson Arizona
United States Palm Beach Cancer Institute West Palm Beach Florida

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Medarex

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czech Republic,  France,  Germany,  Hungary,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 estimate progression free survival rate at Week 12 assessment and other timepoints
Secondary estimate disease control rate at various time points
Secondary estimate overall survival
Secondary estimate survival rate at one year
Secondary evaluate health-related quality of life
Secondary obtain pharmacokinetic samples for population PK analysis
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