Intrathecal Double Checkpoint Inhibition

Sponsor
University of Zurich
Study ID
NCT05598853
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • intrathecal nivolumab and intrathecal ipilimumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 25, 2022
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intrathecal nivolumab and intrathecal ipilimumab
    The experimental treatment will be combined from cycle 2 with systemic nivolumab and systemic ipilimumab

Primary Outcome Measure

Recommended phase II dose of intrathecal (IT) nivolumab/ipilimumab followed by IT nivolumab/ipilimumab plus systemic nivolumab/ipilimumab [ Time Frame: 3 weeks ]

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