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NCT05341349 · ClinicalTrials.gov registry record · Phase 1

Stereotactic Radiosurgery and Immune Checkpoint Inhibitors With NovoTTF-200M for the Treatment of Melanoma Brain Metastases

A Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, sponsored by Emory University.

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

NCT05341349 is a Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain that is active but no longer recruiting, run by Emory University. The registered enrollment target is 1 participants, below the 84-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05341349, a Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, is active but no longer recruiting, sponsored by Emory University.

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

Study Summary

This phase I trial finds out the side effects and possible benefits of stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M for the treating of melanoma that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. It is used to treat brain tumors and other brain disorders that cannot be treated by regular surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. NovoTTF-100M is a portable battery operated device which produces tumor treating fields in the body by means of surface electrodes placed on the skin. Tumor treating fields are low intensity, intermediate frequency electric fields that pulse through the skin to disrupt cancer cells' ability to divide. Giving stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M may work better than stereotactic radiosurgery and immune checkpoint inhibitors.

Conditions Studied

Metastatic Melanoma Metastatic Malignant Neoplasm in the Brain Clinical Stage IV Cutaneous Melanoma AJCC v8 Pathologic Stage IV Cutaneous Melanoma AJCC v8 Metastatic Mucosal Melanoma Melanoma of Unknown Primary Metastatic Ocular Melanoma

Interventions

  • BIOLOGICAL Pembrolizumab
  • BIOLOGICAL Nivolumab
  • RADIATION Stereotactic Radiosurgery
  • BIOLOGICAL Ipilimumab
  • PROCEDURE Tumor Treating Fields Therapy

Study Locations (1)

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2022-10-13
Est. Completion 2027-03-06
Phase Phase 1

Sponsor

Emory University

1,208 total trials

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What the Registry Record Tells You About NCT05341349

The ClinicalTrials.gov registry entry for NCT05341349 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 84-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (99% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT05341349 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT05341349 about?

NCT05341349 is a clinical study titled "Stereotactic Radiosurgery and Immune Checkpoint Inhibitors With NovoTTF-200M for the Treatment of Melanoma Brain Metastases". This phase I trial finds out the side effects and possible benefits of stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M for the treating of melanoma that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of external radiation therapy that use...

What is the current status of trial NCT05341349?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2022-10-13. Estimated completion is 2027-03-06.

What conditions does trial NCT05341349 study?

This clinical trial studies the following conditions: Metastatic Melanoma, Metastatic Malignant Neoplasm in the Brain, Clinical Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Metastatic Mucosal Melanoma.

What interventions are being tested in trial NCT05341349?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Nivolumab (BIOLOGICAL), Stereotactic Radiosurgery (RADIATION), Ipilimumab (BIOLOGICAL), Tumor Treating Fields Therapy (PROCEDURE).

Who is sponsoring clinical trial NCT05341349?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05341349 being conducted?

This trial has 1 study location across Georgia. 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.