A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
NCT ID: NCT00162123
Last Updated: 2016-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
248 participants
INTERVENTIONAL
2006-05-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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First reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
First reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
First reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Extended maintenance: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Extended maintenance: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Extended maintenance: Ipilimumab, 10 mg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
No interventions assigned to this group
Interventions
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Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior treatment in a prespecified prior/parent ipilimumab study
* Men and women 18 years of age and older
First Reinduction:
* No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation
* Had experienced documented progressive disease after expanded clinical benefit
Extended Maintenance
* Received ipilimumab at any dose in a parent study
* Achieved expanded clinical benefit at the time of entry to current study
Follow-up:
* Received ipilimumab at any dose in a closing parent study
* Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up
Exclusion Criteria
* Primary ocular or mucosal melanoma
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Arizona Cancer Center
Tucson, Arizona, United States
Wilshire Oncology Medical Group Inc
Laverne, California, United States
The Angeles Clinic & Research Inst.
Los Angeles, California, United States
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States
San Francisco Oncology Associates
San Francisco, California, United States
Local Institution
To Come, Connecticut, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
University Of Chicago
Chicago, Illinois, United States
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States
St Joseph Oncology Inc
Saint Joseph, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Cancer Centers Of The Carolinas
Greenville, South Carolina, United States
Center For Oncology Research & Treatment, P.A.
Dallas, Texas, United States
Joe Arrington Cancer Research And Treatment Center
Lubbock, Texas, United States
University Of Washington Medical Center
Seattle, Washington, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Vienna, , Austria
Local Institution
Wels, , Austria
Local Institution
Brussels, , Belgium
Local Institution
Brussels, , Belgium
Local Institution
Brussels, , Belgium
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Jaú, São Paulo, Brazil
Local Institution
Calgary, Alberta, Canada
Local Institution
Edmonton, Alberta, Canada
Local Institution
Moncton, New Brunswick, Canada
Local Institution
Olomouc, , Czechia
Local Institution
Aarhus C, , Denmark
Local Institution
Brest, , France
Local Institution
Lyon, , France
Local Institution
Paris, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Berlin, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
Kiel, , Germany
Local Institution
Jerusalem, , Israel
Local Institution
Tel Aviv, , Israel
Local Institution
Genova, , Italy
Local Institution
Meldola (Fc), , Italy
Local Institution
Rimini, , Italy
Local Institution
Siena, , Italy
Local Institution
Oslo, , Norway
Local Institution
Lodz, , Poland
Local Institution
Poznan, , Poland
Local Institution
Wroclaw, , Poland
Local Institution
Saint Petersburg, , Russia
Local Institution
Stavropol, , Russia
Local Institution
Voronezh, , Russia
Local Institution
Johannesburg, Gauteng, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Local Institution
Málaga, , Spain
Local Institution
Valencia, , Spain
Local Institution
Dnipro, , Ukraine
Countries
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References
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Lebbe C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day SJ, Konto C, Cykowski L, McHenry MB, Wolchok JD. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies. Ann Oncol. 2014 Nov;25(11):2277-2284. doi: 10.1093/annonc/mdu441. Epub 2014 Sep 10.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA184-025
Identifier Type: -
Identifier Source: org_study_id
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