drugset / Trial / NCT03025256
Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease
Phase 1
Active not recruiting
75 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I/Ib trial studies the side effects and best dose of intrathecal nivolumab, and how well it works in combination with intravenous nivolumab in treating patients with leptomeningeal disease. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Timeline
- Start
- 2018-05-02
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 5 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 10 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 20 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 50 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |