Clinical trial NCT00289640: Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: Stage III (unresectable)
Stage IV melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Medarex
First posted: 2006-02-10
Enrollment: 210
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: 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:
measure: estimate progression free survival rate at Week 12 assessment and other timepoints
measure: estimate disease control rate at various time points
measure: estimate overall survival
measure: estimate survival rate at one year
measure: evaluate health-related quality of life
measure: obtain pharmacokinetic samples for population PK analysis
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Laverne
country: United States
facility: Wilshire Oncology Medical Group Inc
state: California
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: Santa Monica
country: United States
facility: The Angeles Clinic And Research Institution
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: Md Anderson Cancer Center Orlando
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Park Ridge
country: United States
facility: Oncology Specialists, Sc
state: Illinois
city: Indianapolis
country: United States
facility: American Health Network
state: Indiana
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Harry And Jeanette Weinberg Cancer Inst At Franklin Square
state: Maryland
city: Robbinsdale
country: United States
facility: Hubert H. Humphrey Cancer Center
state: Minnesota
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: St Joseph
country: United States
facility: St Joseph Oncology Inc
state: Missouri
city: St. Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Greenville
country: United States
facility: Cancer Centers Of The Carolinas
state: South Carolina
city: Dallas
country: United States
facility: Center For Oncology Research & Treatment, P.A.
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Newcastle
country: Australia
facility: Local Institution
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Wodonga
country: Australia
facility: Local Institution
state: Victoria
city: Brussels
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Centro-Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Jau
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Kingston
country: Canada
facility: Local Institution
state: Ontario
city: Olomouc
country: Czech Republic
facility: Local Institution
city: Praha
country: Czech Republic
facility: Local Institution
city: Brest
country: France
facility: Local Institution
state: Cedex
city: Clermont Ferrand
country: France
facility: Local Institution
city: Lyon Cedex 08
country: France
facility: Local Institution
city: Lyon
country: France
facility: Local Institution
city: Marseille Cedex 09
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Rennes
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Jena
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Wurzburg
country: Germany
facility: Local Institution
city: Pécs
country: Hungary
facility: Local Institution
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
Study officials:
References:
citation: 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.
citation: Wolchok 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.