Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma
NCT ID: NCT00803374
Last Updated: 2011-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2010-11-30
2013-01-31
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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0.1 mg/kg
AntiCD137
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
0.3 mg/kg
AntiCD137
Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
1.0 mg/kg
AntiCD137
Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
3.0 mg/kg
AntiCD137
Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
10 mg/kg
AntiCD137
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Interventions
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AntiCD137
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
AntiCD137
Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
AntiCD137
Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
AntiCD137
Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
AntiCD137
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
* Willing to undergo up to 3 biopsies of an accessible lesion
Exclusion Criteria
* Primary ocular melanoma or primary tumor of unknown origin
* Concurrent autoimmune disease
* Previous treatment with a CD137 agonist or CTLA-4 inhibitor
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Los Angeles, California, United States
Local Institution
New Haven, Connecticut, United States
Local Institution
Tampa, Florida, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
New York, New York, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA186-007
Identifier Type: -
Identifier Source: org_study_id