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Device
NovoTTF-200A + Pembrolizumab for Melanoma
Phase 1 & 2
Waitlist Available
Led By Eric T Wong
Research Sponsored by Eric Wong, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-1 or Karnofsky ≥80
Have at least 1 untreated brain metastasis for response assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
Study Summary
This trial is studying a device + drug combo as a possible treatment for brain metastases in people with melanoma.
Who is the study for?
Adults with melanoma that has spread to the brain can join this trial. They need measurable disease, a life expectancy over 6 months, and normal organ/marrow function. Participants must be willing to use birth control and have support for device treatment. Excluded are those recently on certain therapies, with hypersensitivities or other cancers, serious health issues like heart conditions or infections, pregnant/breastfeeding women, or uncontrolled illnesses.Check my eligibility
What is being tested?
The study is testing NovoTTF-200A (a device) combined with Pembrolizumab (a drug) for safety and effectiveness in treating brain metastases from melanoma. The goal is to see how well these treatments work together against this advanced stage of skin cancer.See study design
What are the potential side effects?
Possible side effects include skin irritation from the device and immune-related reactions from Pembrolizumab such as inflammation in organs, fatigue, digestive problems, liver issues, hormonal gland changes like thyroid dysfunction; also potential risks of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or able to carry out light work.
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I have at least one untreated brain tumor to be evaluated.
Select...
I can provide tissue samples from a previous biopsy of my tumor.
Select...
I am using two birth control methods or am not having sex to avoid pregnancy during and 120 days after the study.
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I am 18 years old or older.
Select...
My melanoma has spread to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Dose Limiting Toxicity
Secondary outcome measures
12-month Overall Survival Rate
6-month progression-free survival (PFS) rate
Overall Response Rate
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: PHASE 2: NovoTTF-200A + PEMBROLIZUMABExperimental Treatment2 Interventions
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
Group II: PHASE 1: NovoTTF-200A + PEMBROLIZUMABExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NovoTTF-200A
2017
Completed Phase 1
~20
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Eric Wong, MDLead Sponsor
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,324 Total Patients Enrolled
4 Trials studying Melanoma
173,258 Patients Enrolled for Melanoma
NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,692 Total Patients Enrolled
3 Trials studying Melanoma
22 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to the lining of my brain and spinal cord.My organs and bone marrow are functioning normally.I have been treated for an autoimmune disease in the last 2 years.You are allergic to hydrogel.I am currently on medication for an infection.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.I have an active Hepatitis B or C infection.I have not received a live vaccine in the last 30 days.You are expected to live for more than 6 months.I have taken a pregnancy test in the last 14 days and it was negative.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.I have an active case of tuberculosis.Your MRI shows tumors that are at least 10 millimeters in size and can be accurately measured.I am still recovering from major surgery complications.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have another cancer that is getting worse or needs treatment.I am fully active or able to carry out light work.My brain cancer can be measured or seen on tests.I have at least one untreated brain tumor to be evaluated.You have signs of increased pressure inside your skull.I can provide tissue samples from a previous biopsy of my tumor.You have had a bad reaction to pembrolizumab or any of its ingredients before.I haven't taken high doses of steroids or any immunosuppressants in the last week.I have or had lung inflammation not caused by an infection.My melanoma is BRAF positive and I've had issues with BRAF/MEK therapy.I have a pacemaker, defibrillator, or brain stimulator, or I have significant heart rhythm problems.I don't have any health issues that could affect the trial's results.I am using two birth control methods or am not having sex to avoid pregnancy during and 120 days after the study.I have been diagnosed with an immunodeficiency or HIV.I am 18 years old or older.My melanoma has spread to my brain.I agree to use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: PHASE 1: NovoTTF-200A + PEMBROLIZUMAB
- Group 2: PHASE 2: NovoTTF-200A + PEMBROLIZUMAB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What benefits has NovoTTF-200A been shown to provide patients?
"NovoTTF-200A is a common treatment for malignant neoplasms. This tool can also be helpful in managing unresectable melanoma, microsatellite instability high, and chemotherapy side effects."
Answered by AI
Are we still looking for participants for this research project?
"As of right now, this clinical trial is not enrolling patients. According to the latest update on clinicaltrials.gov (9/30/2022), this study was initially posted on December 1st, 2022. Although this specific trial has ended recruitment, there are 2688 other studies that are presently looking for participants."
Answered by AI
Are there any similar studies to the NovoTTF-200A clinical trial?
"NovoTTF-200A was first studied in 2010 at City of Hope. Since the completion of that initial trial, there have been 249 more completed studies. At this moment in time, there are 1000 active trials recruiting patients with a large portion of these clinical tests taking place in Providence, Rhode island."
Answered by AI
How many people are being given the opportunity to participate in this clinical trial?
"This study is no longer recruiting patients. The trial was originally posted on December 1st, 2020 and the listing was last updated on September 30th, 2020. For anyone interested, there are currently 1688 studies actively recruiting patients with melanoma and 1000 studies for NovoTTF-200A admitting patients."
Answered by AI
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