NovoTTF-200A + Pembrolizumab In Melanoma Brain Metastasis

Metastatic Melanoma Clinical Trial

Official title: Phase I and II Study of NovoTTF-200A and Pembrolizumab in Newly Diagnosed Melanoma Brain Metastasis

Status Not yet recruiting

Clinical Trial Summary

This research study involves studying a device as a possible treatment for metastatic melanoma in the brain. The purpose of this study is to obtain information on the safety and effectiveness of the study device, NovoTTF-200A, in melanoma participants with brain metastases when it is combined with Pembrolizumab.

The name of the study device involved in this study is:

-- NovoTTF-200A

The name of the drug used in this study is:

-- Pembrolizumab

Clinical Trial Description

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

• The name of the study device involved in this study is: NovoTTF-200A

• The name of the drug used in this study is: Pembrolizumab

• Eligible participants will be in this research study for up to 2 years, or until progressive disease or unacceptable toxicity as is reflected in the protocol.

• This is a Phase I/II clinical trial.

• A Phase I clinical trial tests the safety and toxicity of adding an investigational device NovoTTF-200A to standard-of-care drug Pembrolizumab to use for further studies.

• A Phase II clinical trial tests how well the combination works for your brain disease. "Investigational" means that the device is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved NovoTTF-200A for your brain metastasis from melanoma.

A metastatic brain tumor is usually found when a cancer patient begins to experience neurological symptoms and a brain scan (CT or MRI) is ordered. However, some participants are symptom-free and are only diagnosed with brain metastases with MRI or CT scans for another reason.

The NovoTTF-200A System is a portable device which produces changing electrical fields, called Tumor Treatment Fields ("TTFields") within the human body. TTFields stop the growth of tumor cells resulting in cell death of the rapidly dividing cancer cells. TTFields may also sensitize the tumor cells to immune therapies and this is the rationale for combining NovoTTF-200A and Pembrolizumab.

The system is a portable, light-weighted, battery operated device designed to deliver TTFields directly to the region where brain metastasis are. The device can be carried backpack while working or doing other activities of daily living. ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Melanoma
• Melanoma Brain Metastasis
• Metastatic Melanoma
• Neoplasm Metastasis

• NCT number: NCT04129515
• Study type: Interventional
• Source: Brown University
• Contact: Eric T Wong, MD
• Phone: 401-444-0115
• Email: ewong1@lifespan.org
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 15, 2024
• Completion date: January 2027