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NCT03025256 · ClinicalTrials.gov registry record · Phase 1

Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease

A Phase 1 study of Metastatic Melanoma and Stage IV Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 1
Development phase
71
Enrollment target
1
Study location

NCT03025256 is a Phase 1 study of Metastatic Melanoma and Stage IV Lung Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 71 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (14% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03025256, a Phase 1 study of Metastatic Melanoma and Stage IV Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
71 participants
Enrollment target
1
Study location

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 Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Lumbar Puncture
  • PROCEDURE Magnetic Resonance Imaging
  • BIOLOGICAL Nivolumab

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2018-05-02
Est. Completion 2025-12-30
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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What the Registry Record Tells You About NCT03025256

The ClinicalTrials.gov registry entry for NCT03025256 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (14% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT03025256 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03025256 about?

NCT03025256 is a clinical study titled "Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease". 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 atta...

What is the current status of trial NCT03025256?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2018-05-02. Estimated completion is 2025-12-30.

What conditions does trial NCT03025256 study?

This clinical trial studies the following conditions: Metastatic Melanoma, Stage IV Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Uveal Melanoma.

What interventions are being tested in trial NCT03025256?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Lumbar Puncture (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Nivolumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03025256?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03025256 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.