NCT04129515

NovoTTF-200A + Pembrolizumab In Melanoma Brain Metastasis

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Metastatic Melanoma
• Melanoma Brain Metastasis

Interventions

Type	Name	Description
DEVICE	NovoTTF-200A	•NovoTTF-200A will be applied continuously, with 21 consecutive days defined as a treatment cycle
DRUG	Pembrolizumab	Pembrolizumab will be administered once every 3 weeks, with 21 consecutive days also defined as a treatment cycle

Timeline

• Start date: 2025-10-30
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2019-10-16
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study