Study of BMS-663513 in Patients With Advanced Cancer

Status:	Terminated
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	December 2005
End Date:	September 2009

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 Malignancies

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.

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.

We found this trial at

sites

Indiana University Cancer Center

Indianapolis, Indiana 46202

from

Indianapolis, IN