To determine the feasibility and explore the anti-tumor activity of intrathecal double immune checkpoint inhibition in patients with newly diagnosed leptomeningeal metastases of non-small cell lung cancer without driver mutation or melanoma.
Aim of the study
In our research project, we want to find out whether treatment with immunotherapy (immune checkpoint antibodies), which is injected locally into the fluid space surrounding the brain and spinal cord (subarachnoid space or cerebrospinal fluid space), is tolerable and enables better control of the tumor disease. This form of local administration of medication is called intrathecal therapy.
Who can take part?
Patients with leptomeningeal metastasis, stage IV non-small cell lung cancer, stage IV melanoma
Procedure
If you decide to participate, you will repeatedly receive the two drugs either via lumbar punctures (injections into the subarachnoid space or cerebrospinal fluid space) or via a surgically inserted reservoir on the head that allows the drugs to be injected directly into the cerebrospinal fluid (CSF). The therapy is applied during outpatient visits to our clinic. Inpatient stays are not necessary. The therapy is administered for as long as it is tolerated and the tumor disease is controlled, for up to 24 months. The injections are initially given 5 times at 3-week intervals and later at 4-week intervals.
Compensation
None
Original study name
Intrathecal administration of anti-PD1/anti-CTLA-4 in combination with a systemic combination of anti-PD1/anti-CTLA-4 in patients with non-small cell lung cancer without oncogenic driver mutation or melanoma and newly diagnosed leptomeningeal metastasis: a multicenter phase I study
BASEC number
2022-01055
Financial support from
University of Zurich