At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at informed consent
- ✓Good NCCN risk status
- ✓Tumor board confirmation of clinical recommendation for intrathecal therapy and trial enrollment evaluation
- ✓LMD diagnosis confirmed by CSF and/or MRI
- ✕Women during pregnancy and lactation
- ✕Previous intrathecal nivolumab application
- ✕Poor NCCN risk status
- ✕Differential diagnoses: aseptic meningitis, viral meningitis, bacterial meningitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease (IT-PD1/ NOA 26)
In Brief
A Phase 1 clinical trial evaluating Nivolumab [Opdivo] for Leptomeningeal Disease. Currently recruiting, targeting 46 participants across 9 sites.
Signals
Detailed Summary
To determine the safety of intrathecal (IT) PD1 antibody for Intrathecal application of PD1 antibody in metastatic solid tumors with leptomeningeal disease of solid tumors.
Study Details
Timeline
Interventions
Nivolumab (OPDIVO®) is a marketed pharmaceuticals material authorized in the European Union. This study uses an off-label route of administration of nivolumab. Subjects with leptomeningeal disease in solid tumours with an approved indication for intravenous treatment with the PD1 antibody will receive an intrathecal application of nivolumab. A total of six i.th. applications will be performed every 14 days. The intrathecal administration will be performed via an Ommaya reservoir or another intraventricular catheter.