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

Phase 2

Completed

• Conditions: Melanoma
• Interventions: Drug: ipilimumab (MDX-010, BMS-734016); Drug: Ipilimumab

• Registration Number: NCT00289640
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Study Start: 2006-04
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2009-01
• Disposition First Submitted: 2010-02-27
• Disposition First Submitted QC: 2010-02-27
• Last Update Submitted: 2010-02-27
• Disposition First Posted: 2010-03-02
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ipilimumab (MDX-010, BMS-734016)	-
2	Ipilimumab	-
3	Ipilimumab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (26)

Center For Oncology Research & Treatment, P.A.; 🇺🇸 Dallas, Texas, United States

Oncology Specialists, Sc; 🇺🇸 Park Ridge, Illinois, United States

St Joseph Oncology Inc; 🇺🇸 St Joseph, Missouri, United States

Yale University School Of Medicine; 🇺🇸 New Haven, Connecticut, United States

Wilshire Oncology Medical Group Inc; 🇺🇸 Laverne, California, United States

University Of Louisville; 🇺🇸 Louisville, Kentucky, United States

Cancer Centers Of The Carolinas; 🇺🇸 Greenville, South Carolina, United States

Local Institution; 🇿🇦 Cape Town, Western Cape, South Africa

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Baptist Cancer Institute; 🇺🇸 Jacksonville, Florida, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

The Angeles Clinic And Research Institution; 🇺🇸 Santa Monica, California, United States

Palm Beach Cancer Institute; 🇺🇸 West Palm Beach, Florida, United States

Harry And Jeanette Weinberg Cancer Inst At Franklin Square; 🇺🇸 Baltimore, Maryland, United States

Ellis Fischel Cancer Center; 🇺🇸 Columbia, Missouri, United States

Washington University School Of Medicine; 🇺🇸 St. Louis, Missouri, United States

Mount Sinai Comprehensive Cancer Center; 🇺🇸 Miami Beach, Florida, United States

Md Anderson Cancer Center Orlando; 🇺🇸 Orlando, Florida, United States

Hubert H. Humphrey Cancer Center; 🇺🇸 Robbinsdale, Minnesota, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Scripps Cancer Center; 🇺🇸 San Diego, California, United States

American Health Network; 🇺🇸 Indianapolis, Indiana, United States

The Christ Hospital Cancer Center Research; 🇺🇸 Cincinnati, Ohio, United States

Mary Crowley Medical Research Center; 🇺🇸 Dallas, Texas, United States

Presbyterian Hospital; 🇺🇸 Charlotte, North Carolina, United States