Intrathecal nivolumab in metastatic solid tumors with leptomeningeal disease: dose escalation part of the multicenter IT-PD1/NOA-26 phase 1 trial - PubMed
5 hours ago
- #phase 1 trial
- #leptomeningeal disease
- #intrathecal immunotherapy
- Intrathecal nivolumab was studied in a phase 1 trial for metastatic solid tumors with leptomeningeal disease (LMD).
- The trial included 30 enrolled participants, with 24 receiving at least one dose and 18 completing safety evaluations.
- Dose escalation tested four levels (20, 30, 40, and 50 mg), with one dose-limiting toxicity at 40 mg.
- The primary safety endpoint was met, and the recommended fixed dose for further studies is 50 mg.
- Median overall survival was 6.6 months, with 6-month, 12-month, and 18-month survival rates reported as 55.0%, 33.3%, and 16.7%, respectively.
- Patient-reported quality of life remained stable during the trial.
- Intraventricular nivolumab demonstrated safety and feasibility, and the expansion part of the trial is ongoing.