Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma
- Registration Number
- NCT00803374
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Histologically or cytologically confirmed malignant melanoma
- 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
- Active/symptomatic brain metastases
- Primary ocular melanoma or primary tumor of unknown origin
- Concurrent autoimmune disease
- Previous treatment with a CD137 agonist or CTLA-4 inhibitor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.1 mg/kg AntiCD137 - 3.0 mg/kg AntiCD137 - 0.3 mg/kg AntiCD137 - 10 mg/kg AntiCD137 - 1.0 mg/kg AntiCD137 - 0.1 mg/kg Ipilimumab - 0.3 mg/kg Ipilimumab - 1.0 mg/kg Ipilimumab - 3.0 mg/kg Ipilimumab - 10 mg/kg Ipilimumab -
- Primary Outcome Measures
Name Time Method Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received
- Secondary Outcome Measures
Name Time Method Evidence of clinical improvement in tumor burden confirmed by CT or MRI Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter
Trial Locations
- Locations (1)
Local Institution
🇺🇸New York, New York, United States