Study of BMS-663513 in Patients With Advanced Cancer
- Registration Number
- NCT00309023
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137 monoclonal antibody, administered every three weeks to patients with metastatic or locally advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 115
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) score of 0-1.
- Measurable disease.
- Absolute neutrophil count (ANC) >= 1,500 cells/mm3
- Platelet count >= 100K cells/mm3
- Hemoglobin >= 9.0 g/dL
- Total bilirubin <= 1.5 x IULN
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase <= 2.5 x institutional upper limit of normal (IULN)
- Patients with advanced solid malignancies must have melanoma, renal or ovarian carcinoma
Exclusion Criteria
- History of autoimmune diseases.
- Condition requiring the continued use of systemic or topical steroids or the use of immunosuppressive agents.
- Active/symptomatic brain metastasis.
- History of hepatitis B or C.
- Concurrent malignancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dose escalation BMS-663513 -
- Primary Outcome Measures
Name Time Method Assess Safety (Number and distribution and severity adverse events) of subjects Active treatment of a minimum of 3 months up until disease progression or toxicity; and long-term follow-up to assess time to progression or death will conclude 2 years after the last treatment with BMS-663513.
- Secondary Outcome Measures
Name Time Method Assess pharmacokinetic parameters deriving from serum concentration versus time data Cycle 1 Day 1, Cycle 2 Day 1 and 28, Cycle 3 Day 1 and 8, and Day 1 of every cycle the subject is on study from Cycle 4 and greater; and at study discharge. Efficacy by evaluation of tumor response At week 12 and every 6 weeks thereafter. Follow-up up to 2 years after last dose of study drug Assess pharmacodynamic and immune response analysis up to 60 days after last dose of study drug
Trial Locations
- Locations (7)
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
City Of Hope National Medical Center
🇺🇸Duarte, California, United States
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Local Institution
🇫🇷Villejuif Cedex, France
Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States