Study of BMS-663513 in Patients With Advanced Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Tumors

In brief

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.

Key facts

Study ID

NCT00309023

Run by

Bristol-Myers Squibb

People needed

115

Starts

2005-12-01

Expected to finish

2009-09-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Bordeaux, France
• Local Institution — Paris, France
• Local Institution — Paris, France
• Local Institution — Saint-Herblain, France
• Local Institution — Villejuif, France

Full record on ClinicalTrials.gov

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