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Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease

NCT03025256 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-05

No results posted yet for this study

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.

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

Interventions

PROCEDURE

Biospecimen Collection

Correlative studies

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture for cerebrospinal fluid collection

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI of brain and spine

BIOLOGICAL

Nivolumab

Given IV or IT

PROCEDURE

Positron Emission Tomography

Undergo PET

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Isabella C Glitza, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-02
Primary Completion
2027-06-01
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03025256 on ClinicalTrials.gov