Spots Global Cancer Trial Database for Intrathecal Double Checkpoint Inhibition

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Trial Identification

Brief Title: Intrathecal Double Checkpoint Inhibition

Official Title: Intrathecal Administration of Anti-PD1/Anti-CTLA-4 in Combination With Systemic Combination of Anti-PD1/Anti-CTLA-4 in Patients With NSCLC Without Oncogenic Driver Mutation or Melanoma and Newly Diagnosed Leptomeningeal Metastasis: a Multicentric Phase I Study

Study ID: NCT05598853

Conditions

Leptomeningeal Metastasis

Non-small Cell Lung Cancer Stage IV

Melanoma Stage IV

Interventions

intrathecal nivolumab and intrathecal ipilimumab

Study Description

Brief Summary: The objective of the present study is to determine the feasibility and to explore anti-tumor activity of intrathecal double immune checkpoint inhibition for patients with newly diagnosed leptomeningeal metastases from non-small cell lung cancer without driver mutation or melanoma.

Detailed Description: The treatment regimen within the IT-IO study consists of intrathecal administration of nivolumab/ipilimumab in combination with systemic combined nivolumab/ipilimumab. The scheme of administration of systemic nivolumab/ipilimumab corresponds to the current standard of care for non-small cell lung cancer and for melanoma patients.