A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
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
1 other identifier
interventional
155
10 countries
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2006
Shorter than P25 for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2006
CompletedFirst Posted
Study publicly available on registry
February 10, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedSeptember 28, 2016
September 1, 2016
1.2 years
February 9, 2006
September 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
Secondary Outcomes (11)
estimate disease control rate
estimate progression free survival rate at Week 12
estimate PFS
estimate overall survival
estimate survival rate at one year
- +6 more secondary outcomes
Study Arms (1)
ipilimumab (MDX-010, BMS-734016)
EXPERIMENTALInterventions
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Eligibility Criteria
You may qualify if:
- Patients with previously treated Stage III (unresectable)or Stage IV melanoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Medarexcollaborator
Study Sites (53)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Park Ridge, Illinois, United States
Unknown Facility
Goshen, Indiana, United States
Unknown Facility
Hazard, Kentucky, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Charlottesvillle, Virginia, United States
Local Institution
Salzburg, Austria
Local Institution
Vienna, Austria
Local Institution
Wels, Austria
Local Institution
Turku, Finland
Local Institution
Genova, Italy
Local Institution
Meldola, Italy
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Milan, Italy
Local Institution
Napoli, Italy
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Padua, Italy
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Siena, Italy
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Torino, Italy
Local Institution
Oslo, Norway
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Lodz, Poland
Local Institution
Poznan, Poland
Local Institution
Wroclaw, Poland
Local Institution
Barnaul, Russia
Local Institution
Moscow, Russia
Local Institution
Murmansk, Russia
Local Institution
Ryazan, Russia
Local Institution
Saint Petersburg, Russia
Local Institution
Samara, Russia
Local Institution
Stavropol, Russia
Local Institution
Veliky Novgorod, Russia
Local Institution
Voronezh, Russia
Local Institution
Barcelona, Spain
Local Institution
Madrid, Spain
Local Institution
Málaga, Spain
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Santa Cruz de Tenerife, Spain
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Valencia, Spain
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Gothenburg, Sweden
Local Institution
Lund, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Cherkassy, Ukraine
Local Institution
Dnipropetrovsk, Ukraine
Local Institution
Kiev, Ukraine
Local Institution
Lviv, Ukraine
Local Institution
Sumy, Ukraine
Local Institution
Uzhhorod, Ukraine
Related Publications (2)
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.
PMID: 25667295DERIVEDDi 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.
PMID: 19139884DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 9, 2006
First Posted
February 10, 2006
Study Start
April 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
September 28, 2016
Record last verified: 2016-09