At a glance
ClinicalIndex Comparison Record- ✓Radiographic and/or CSF cytological evidence of leptomeningeal disease (LMD)
- ✓Confirmed diagnosis of primary CNS melanoma, melanocytomas, or metastatic melanoma (cutaneous, acral-lentiginous, uveal, mucosal) OR non-small cell lung cancer
- ✓ECOG performance status ≤2
- ✓Age ≥18 years
- ✕Active autoimmune disease requiring systemic treatment in past 2 years
- ✕Corticosteroids >4 mg daily dexamethasone equivalents within 14 days of study drug
- ✕Ongoing >grade 2 adverse events from prior anti-PD-1 or anti-CTLA-4 therapy
- ✕Currently receiving active cancer therapy (except approved targeted therapies)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Melanoma and Lung Cancer Patients With Leptomeningeal Disease (LMD)
In Brief
A Phase 1 clinical trial evaluating Biospecimen Collection, Computed Tomography, and 4 other interventions for Acral Lentiginous Melanoma and 9 related conditions. Active but no longer recruiting, targeting 75 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Patients receive nivolumab IT over 5 minutes on day 1 of every cycle. Beginning in cycle 2, patients also receive nivolumab IV over 30 minutes on day 1 (4 hours after the IT dose). Cycles repeat every 14 days for 18 cycles and then every 28 days (cycles 19 and beyond) in the absence of disease progression or unacceptable toxicity. Patients will have CSF and blood specimen collection on days 1, 2, 8 of each cycle and end of treatment. Patients undergo CT or PET at baseline, cycle 5 and then every 8 weeks. Patients undergo MRI at baseline, cycles 3, 5, and then every 8 weeks.
Interventions
Correlative studies
Undergo CT
Undergo lumbar puncture for cerebrospinal fluid collection
Undergo MRI of brain and spine
Given IV or IT
Undergo PET