NCT05598853

Intrathecal Double Checkpoint Inhibition

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leptomeningeal Metastasis
• Non-small Cell Lung Cancer Stage IV
• Melanoma Stage IV

Interventions

Type	Name	Description
DRUG	intrathecal nivolumab and intrathecal ipilimumab	Patients shall be treated with a fixed dose of intrathecal nivolumab and increasing doses of intrathecal ipilimumab. From cycle 2, patients will receive systemic nivolumab/ipilimumab in addition to intrathecal treatment. Systemic nivolumab/ipilimumab corresponds to the current standard of care for non-small cell lung cancer and for melanoma patients.

Timeline

• Start date: 2022-11-25
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-10-28
• Last updated: 2025-10-02

Locations

3 sites across 1 country: Switzerland

Regulatory

• FDA-regulated drug study