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RATIONALE: Monoclonal antibodies, such as ticilimumab and CD40 agonist monoclonal antibody CP-870,893, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving ticilimumab together with CD 40 agonist monoclonal antibody CP-870, 893 may kill more tumor cells.
I. To assess the safety, dose-limiting toxicities and maximum tolerated doses of tremelimumab (administered intravenously every 12 weeks) and CP- 870,893 (administered intravenously every 3 weeks).
I To seek preliminary evidence of anti-tumor efficacy of the combination of tremelimumab and CP-870,893, including objective response rate at MTD.
II. To determine the immune pharmacodynamic changes associated with the administration of the combination of tremelimumab and CP-870,893.
OUTLINE: Patients receive ticilimumab IV over 1 hour on day 1 and CD40 agonist monoclonal antibody CP-870,893 IV over 30 minutes on days 2, 22, 43, and 64. Treatment repeats every 12 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
CD40 agonist monoclonal antibody CP-870,893, ticilimumab, laboratory biomarker analysis
Abramson Cancer Center of The University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Published on BioPortfolio: 2014-08-27T03:14:34-0400
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