Back to resultsA Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ipilimumab (MDX-010, BMS-734016)
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Previously treated melanoma, Unresectable Stage III, Stage IV
Eligibility Criteria
Inclusion Criteria: Patients with previously treated Stage III (unresectable)or Stage IV melanoma
Sites / Locations
- Local Institution
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ipilimumab (MDX-010, BMS-734016)
Arm Description
Outcomes
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
Full Information
NCT ID
NCT00289627
First Posted
February 9, 2006
Last Updated
September 27, 2016
Sponsor
Bristol-Myers Squibb
Collaborators
Medarex
1. Study Identification
Unique Protocol Identification Number
NCT00289627
Brief Title
A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Medarex
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Previously treated melanoma, Unresectable Stage III, Stage IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ipilimumab (MDX-010, BMS-734016)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ipilimumab (MDX-010, BMS-734016)
Intervention Description
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Primary Outcome Measure Information:
Title
Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
Secondary Outcome Measure Information:
Title
estimate disease control rate
Title
estimate progression free survival rate at Week 12
Title
estimate PFS
Title
estimate overall survival
Title
estimate survival rate at one year
Title
estimate duration of BOR
Title
evaluate proportion of patients whose duration of response is >=24 weeks
Title
estimate time to BOR
Title
evaluate safety profile of ipilimumab during the induction and maintenance phases
Title
evaluate health-related quality of life
Title
obtain PK sample for population PK analysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with previously treated Stage III (unresectable)or Stage IV melanoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Santa Monica
State/Province
California
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Park Ridge
State/Province
Illinois
Country
United States
City
Goshen
State/Province
Indiana
Country
United States
City
Hazard
State/Province
Kentucky
Country
United States
City
Alburquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Charlottesvillle
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Salzburg
Country
Austria
Facility Name
Local Institution
City
Wels
Country
Austria
Facility Name
Local Institution
City
Wien
Country
Austria
Facility Name
Local Institution
City
Turku
Country
Finland
Facility Name
Local Institution
City
Genova
Country
Italy
Facility Name
Local Institution
City
Meldola
Country
Italy
Facility Name
Local Institution
City
Milano
Country
Italy
Facility Name
Local Institution
City
Napoli
Country
Italy
Facility Name
Local Institution
City
Padova
Country
Italy
Facility Name
Local Institution
City
Siena
Country
Italy
Facility Name
Local Institution
City
Torino
Country
Italy
Facility Name
Local Institution
City
Oslo
Country
Norway
Facility Name
Local Institution
City
Lodz
Country
Poland
Facility Name
Local Institution
City
Poznan
Country
Poland
Facility Name
Local Institution
City
Wroclaw
Country
Poland
Facility Name
Local Institution
City
Barnaul
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
Country
Russian Federation
Facility Name
Local Institution
City
Murmansk
Country
Russian Federation
Facility Name
Local Institution
City
Ryazan
Country
Russian Federation
Facility Name
Local Institution
City
Samara
Country
Russian Federation
Facility Name
Local Institution
City
St Petersburg
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
Country
Russian Federation
Facility Name
Local Institution
City
Stavropol
Country
Russian Federation
Facility Name
Local Institution
City
Velikiy Novgorod
Country
Russian Federation
Facility Name
Local Institution
City
Voronezh
Country
Russian Federation
Facility Name
Local Institution
City
Barcelona
Country
Spain
Facility Name
Local Institution
City
Madrid
Country
Spain
Facility Name
Local Institution
City
Malaga
Country
Spain
Facility Name
Local Institution
City
Tenerife
Country
Spain
Facility Name
Local Institution
City
Valencia
Country
Spain
Facility Name
Local Institution
City
Goteborg
Country
Sweden
Facility Name
Local Institution
City
Lund
Country
Sweden
Facility Name
Local Institution
City
Stockholm
Country
Sweden
Facility Name
Local Institution
City
Uppsala
Country
Sweden
Facility Name
Local Institution
City
Cherkassy
Country
Ukraine
Facility Name
Local Institution
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Local Institution
City
Kiev
Country
Ukraine
Facility Name
Local Institution
City
Lvov
Country
Ukraine
Facility Name
Local Institution
City
Sumy
Country
Ukraine
Facility Name
Local Institution
City
Uzhgorod
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
25667295
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.
Results Reference
derived
PubMed Identifier
19139884
Citation
Di Giacomo AM, Danielli R, Guidoboni M, Calabro 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. doi: 10.1007/s00262-008-0642-y. Epub 2009 Jan 13.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
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