OncRef

Clinical Trial: NCT03025256

Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:M.D. Anderson Cancer Center
Information Provided By:M.D. Anderson Cancer Center
Last Update Posted:2026-08-19

Study Overview

Brief 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.

Official Title

Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Melanoma and Lung Cancer Patients With Leptomeningeal Disease (LMD)

Conditions

Acral Lentiginous Melanoma, Central Nervous System Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Leptomeningeal Neoplasm, Melanocytoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Melanoma, Metastatic Mucosal Melanoma, Metastatic Uveal Melanoma, Stage IV Lung Cancer AJCC v8

Intervention / Treatment

  • Procedure: Biospecimen Collection
  • Procedure: Computed Tomography
  • Procedure: Lumbar Puncture
  • Procedure: Magnetic Resonance Imaging
  • Biological: Nivolumab
  • Procedure: Positron Emission Tomography

Other Study ID Numbers

  • 2016-0567
  • NCI-2018-01211
  • 2016-0567

Start Date (Actual)

2018-05-02

Primary Completion Date (Estimated)

2027-06-01

Study Completion Date (Estimated)

2027-06-01

Enrollment (Actual)

75

Study Type

Interventional

Phase

Phase 1