NovoTTF-200A + Pembrolizumab In Melanoma Brain Metastasis
- Conditions
- Metastatic MelanomaMelanoma Brain Metastasis
- Interventions
- Device: NovoTTF-200A
- Registration Number
- NCT04129515
- Lead Sponsor
- Brown University
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PHASE 1: NovoTTF-200A + PEMBROLIZUMAB NovoTTF-200A The Phase I portion of the study will have a 3 + 3 design and consist of one cohort treated * NovoTTF-200A will be applied continuously, with 21 consecutive days defined as a treatment cycle. * Pembrolizumab will be administered once every 3 weeks, with 21 consecutive days also defined as a treatment cycle PHASE 2: NovoTTF-200A + PEMBROLIZUMAB NovoTTF-200A * NovoTTF-200A will be applied continuously, with 21 consecutive days defined as a treatment cycle. * Pembrolizumab will be administered once every 3 weeks, with 21 consecutive days also defined as a treatment cycle PHASE 1: NovoTTF-200A + PEMBROLIZUMAB Pembrolizumab The Phase I portion of the study will have a 3 + 3 design and consist of one cohort treated * NovoTTF-200A will be applied continuously, with 21 consecutive days defined as a treatment cycle. * Pembrolizumab will be administered once every 3 weeks, with 21 consecutive days also defined as a treatment cycle PHASE 2: NovoTTF-200A + PEMBROLIZUMAB Pembrolizumab * NovoTTF-200A will be applied continuously, with 21 consecutive days defined as a treatment cycle. * Pembrolizumab will be administered once every 3 weeks, with 21 consecutive days also defined as a treatment cycle
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Limiting Toxicity 21 Days Dose limited toxicity is considered grade 3 or higher treatment-related adverse events.
- Secondary Outcome Measures
Name Time Method Quality of Life Assessment Baseline, 63 Days, 129 Days, 189 Days, 30 days after last study treatment European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) has been used extensively in many cancer clinical trials and it is supplemented by the EORTC QLQ Brain Neoplasm 20 (BN20), which was developed specifically for patients with brain cancer.
The EORTC QLQ-C30 consists of 30 items and the measurement ranges from 0 to 100, with higher score meaning better outcome in the Global Health Status domain but worse outcomes in the Functional and Symptom Scales.
The EORTC QLQ-BN20 consists of 20 items and the measurement ranges from 0 to 100, with higher score meaning worse outcome in 4 scales (future uncertainty, visual disorder, motor dysfunction and communication deficit) and 7 individual items (headache, seizure, drowsiness, hair loss, itchy skin, weakness of legs and bladder control).12-month Overall Survival Rate 1 Year after last study treatment Kaplan-Meir estimates
6-month progression-free survival (PFS) rate 6 months after last study treatment Kaplan-Meir estimates
Overall Response Rate defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive up to 100 months
Trial Locations
- Locations (1)
Lifespan Cancer Institute
🇺🇸Providence, Rhode Island, United States