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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be asymptomatic at time of getting SRS (day 0) on trial. Prednisone =< 20 mg/day (4 mg or less of dexamethasone equivalent) for at least 7 days prior to treatment is allowed
Eligible for hypofractionation approach (9 Gy x 3 or 6 Gy x 5). 9 Gyx 3 is preferred approach, but 6 Gy x 5 fractions is acceptable
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom srs to death, assessed up to 2 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new treatment for melanoma that has spread to the brain. The treatment is a combination of radiation therapy and immunotherapy, and it is being delivered using a new device. The goal of the trial is to see if this new treatment is more effective than the standard treatment.
Eligible Conditions
- Metastatic Melanoma
- Cutaneous Melanoma
- Melanoma
- Brain Metastasis
- Ocular Melanoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You should not have any symptoms when starting the treatment, and if you are taking prednisone, the dose should be 20 mg or less per day.
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You can receive radiation treatment in fewer, higher doses over a shorter period of time.
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You have at least one detectable tumor outside the brain.
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Your body has enough white blood cells to fight infections.
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Your platelet count is at least 100,000 per microliter.
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Your hemoglobin levels should be at least 9 g/dL or 5.6 mmol/L without needing a blood transfusion or medication to boost red blood cell production.
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Your kidney function needs to be normal, with a certain level of creatinine in your blood or a high enough glomerular filtration rate.
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You have been diagnosed with malignant melanoma.
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You should be in good physical condition with minimal limitations in daily activities.
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You must have been diagnosed with melanoma using a tissue sample.
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We prefer patients who haven't had any immunotherapy before. But if the main doctor says it's okay, we might allow patients who have had a specific type of immunotherapy and have limited disease progression.
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People with melanoma in the eye, on the skin lining the body's openings, or with an unknown starting point for the melanoma can join the study.
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You have 1-10 untreated brain metastases at the time of your initial brain metastases diagnosis. If you had surgery to remove at least one of the brain lesions, the doctor will wait for a few weeks after the surgery before starting the treatment.
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This criterion states that participants must be suitable for both immunotherapy and TTFields treatment. During a specific type of radiation treatment (SRS), the wires for TTFields will be disconnected and then reconnected right after each session. This is to prevent any electrical issues that may happen during the radiation treatment.
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If you had radiation treatment for melanoma in the past, you can still participate.
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Your standard blood tests need to be done within 28 days before joining the study.
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Your bilirubin levels in the blood are within a certain range.
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Your liver function tests should show levels within a certain range, unless you have liver metastases, in which case a higher range is allowed.
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Your albumin level in your blood is 2.5 mg/dL or higher within the past 28 days.
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Your blood clotting time is within the normal range, unless you are taking medication to prevent blood clots and your clotting time is at the right level for that medication.
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Your blood clotting time should not be more than 1.5 times the upper limit of normal, unless you are taking specific blood-thinning medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from srs to death, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from srs to death, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The percentage of patients developing grade 3 CNS toxicity
Secondary outcome measures
Intracranial control
Overall survival (OS)
Progression free survival (PFS)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (nivolumab, ipilimumab, SRS, TTFields)Experimental Treatment4 Interventions
Patients receive standard of care nivolumab and ipilimumab and undergo 3-5 fractions SRS. Patients also undergo TTFields over 8 hours daily using NovoTTF-100M device until intra-cranial progression or until end of immunotherapy treatments at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (SRS, pembrolizumab, TTFields)Experimental Treatment3 Interventions
Patients receive standard of care pembrolizumab and undergo 3-5 fractions SRS. Patients also undergo TTFields over 8 hours daily using NovoTTF-100M device until intra-cranial progression or until end of immunotherapy treatments at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4120
Pembrolizumab
2017
Completed Phase 3
~2030
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Ipilimumab
2014
Completed Phase 3
~2690
Find a Location
Who is running the clinical trial?
NovoCure Ltd.Industry Sponsor
55 Previous Clinical Trials
4,548 Total Patients Enrolled
3 Trials studying Melanoma
42 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,492 Previous Clinical Trials
41,267,571 Total Patients Enrolled
557 Trials studying Melanoma
160,612 Patients Enrolled for Melanoma
Emory UniversityLead Sponsor
1,604 Previous Clinical Trials
2,885,504 Total Patients Enrolled
7 Trials studying Melanoma
176 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical device implanted in your body.You have a sensitivity or allergy to the gel used for ECG or nerve stimulation.You are currently in another research study using a new treatment, or you have a weakened immune system, or you are taking certain medications that affect the immune system.You have a current case of tuberculosis.You are allergic to pembrolizumab or ipilimumab.You are allergic to the hydrogel used for the treatment.You show signs of high pressure inside your head, like symptoms or test results that indicate this.Your brain has shifted more than 5 millimeters from its normal position.You have a serious swelling of the optic nerve in your eye.You have nausea and vomiting caused by increased pressure in your head.You have a history of lung inflammation that needed steroids or currently have lung inflammation.You should not have any symptoms when starting the treatment, and if you are taking prednisone, the dose should be 20 mg or less per day.You have a weakened immune system or are taking certain medications that lower your body's ability to fight off infections.You cannot have an MRI scan for planning and follow-up of treatment.You have a condition where your immune system attacks your own body and have been treated with strong medications for it in the past 2 years.You have decreased alertness because of increased pressure inside your head.You can receive radiation treatment in fewer, higher doses over a shorter period of time.You have at least one detectable tumor outside the brain.Your body has enough white blood cells to fight infections.Your platelet count is at least 100,000 per microliter.Your hemoglobin levels should be at least 9 g/dL or 5.6 mmol/L without needing a blood transfusion or medication to boost red blood cell production.Your kidney function needs to be normal, with a certain level of creatinine in your blood or a high enough glomerular filtration rate.You have received chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks before the study starts, and have not fully recovered from any side effects.If you have mild neuropathy (up to grade 2), you may still be able to join the study.You have another type of cancer that is getting worse or needs ongoing treatment, except for certain types of skin cancer or early-stage cervical cancer.You have a currently active hepatitis B or hepatitis C infection.You have been diagnosed with malignant melanoma.Your liver function tests should show levels within a certain range, unless you have liver metastases, in which case a higher range is allowed.Your albumin level in your blood is 2.5 mg/dL or higher within the past 28 days.Your blood clotting time is within the normal range, unless you are taking medication to prevent blood clots and your clotting time is at the right level for that medication.Your blood clotting time should not be more than 1.5 times the upper limit of normal, unless you are taking specific blood-thinning medication.You have tumors in specific parts of your brain.You have a current infection that needs medication to be treated.You have been diagnosed with HIV.You have a pacemaker, defibrillator, deep brain stimulator, or serious heart rhythm problems.You should be in good physical condition with minimal limitations in daily activities.You must have been diagnosed with melanoma using a tissue sample.We prefer patients who haven't had any immunotherapy before. But if the main doctor says it's okay, we might allow patients who have had a specific type of immunotherapy and have limited disease progression.People with melanoma in the eye, on the skin lining the body's openings, or with an unknown starting point for the melanoma can join the study.You have 1-10 untreated brain metastases at the time of your initial brain metastases diagnosis. If you had surgery to remove at least one of the brain lesions, the doctor will wait for a few weeks after the surgery before starting the treatment.This criterion states that participants must be suitable for both immunotherapy and TTFields treatment. During a specific type of radiation treatment (SRS), the wires for TTFields will be disconnected and then reconnected right after each session. This is to prevent any electrical issues that may happen during the radiation treatment.If you had radiation treatment for melanoma in the past, you can still participate.Your standard blood tests need to be done within 28 days before joining the study.Your bilirubin levels in the blood are within a certain range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (SRS, pembrolizumab, TTFields)
- Group 2: Arm II (nivolumab, ipilimumab, SRS, TTFields)
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.
To what extent could Tumor Treating Fields Therapy be detrimental to human health?
"Our team has evaluated the safety of Tumor Treating Fields Therapy with a score of 1, due to its status as an early-stage clinical trial which has limited evidence for both efficacy and safety."
Answered by AI
What are the key goals of this clinical investigation?
"According to the trial sponsor, NovoCure Ltd., the primary endpoint of efficacy that will be evaluated over a 3-month period is incidence of grade 3 central nervous system toxicity. In addition, this study will also measure secondary endpoints including intracranial control (time without evidence of tumor progression), overall survival, and rates of skin toxicity (as measured by CTCAE 5.0). To assess these outcomes, investigators plan on using Kaplan-Meier methods for estimation with 95% confidence intervals calculated via Greenwood formula or Brookmeyer-Crowley approach as appropriate. Results from each arm will be analyzed separately."
Answered by AI
Are potential participants still being accepted for this research endeavor?
"The records on clinicaltrials.gov suggest that this medical study is no longer recruiting participants, as it was initially posted in December 1st 2022 and most recently updated in August 23rd 2022. Despite this trial not being active anymore, there are still 3,400 other studies currently enrolling patients at the moment."
Answered by AI
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