Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease

Summary

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Description

PRIMARY OBJECTIVE: I. To determine the safety and/or recommended dose of intrathecal (IT) nivolumab in combination with systemic nivolumab treatment in patients with leptomeningeal disease (LMD). SECONDARY OBJECTIVES: I. To assess overall survival with combined intrathecal and systemic administratio...

PRIMARY OBJECTIVE: I. To determine the safety and/or recommended dose of intrathecal (IT) nivolumab in combination with systemic nivolumab treatment in patients with leptomeningeal disease (LMD). SECONDARY OBJECTIVES: I. To assess overall survival with combined intrathecal and systemic administration of nivolumab in this patient population. EXPLORATORY OBJECTIVES: I. Compare the immunological effects of this treatment on immune cells in the cerebrospinal fluid (CSF) to those observed in the peripheral blood and in non-LMD tumors. II. Evaluation of predictors (clinical, molecular, and/or immune) of the efficacy and safety of this regimen. III. To assess the effect of nivolumab on subsequent treatment. IV. To compare levels of nivolumab in the CSF and peripheral blood. OUTLINE: This is a phase I, dose-escalation study followed by a phase Ib study. Patients receive nivolumab IT over 5 minutes on day 1 of every cycle. Beginning in cycle 2, patients also receive nivolumab intravenously (IV) over 30 minutes on day 1 (4 hours after the IT dose). Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 4 weeks and then every 12 weeks thereafter.

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