Study of Concurrent Intravenous and Intrathecal Nivolumab for Patients With Leptomeningeal Disease (LMD)
Status:
Not yet recruiting
Trial end date:
0000-00-00
Target enrollment:
Participant gender:
Summary
This clinical research study consists of 2 phases: dose escalation (Phase 1) and dose
expansion (Phase 2).
The goal of Phase 1 of this research study is to find the highest tolerable dose level of
nivolumab that can be given both by intravenous (IV) infusion and intrathecal (IT) injection
to patients with leptomeningeal disease (LMD). IV infusions are given by vein, while IT
injections are given directly into the cerebrospinal fluid (CSF).
The goal of Phase 2 of this research study is to learn if the highest tolerable dose level
combination found during Phase 1 can help to control the disease.
The safety of the drug combination will also be studied in both phases.