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Checkpoint Inhibitor
Radiotherapy + Immunotherapy for Melanoma Brain Metastasis
Phase 1
Recruiting
Led By Mohammad K Khan, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have at least one measurable extra-cranial site of disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 or Karnofsky performance status >= 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from srs to death, assessed up to 2 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with melanoma that has spread to the brain. Participants must be in good health otherwise, able to consent, and have not received certain treatments recently. They should also agree to use birth control if of childbearing potential and need a caregiver or self-support for device management.Check my eligibility
What is being tested?
The study tests combining stereotactic radiosurgery (precise radiation therapy) with immune checkpoint inhibitors (drugs like pembrolizumab, nivolumab, ipilimumab) and NovoTTF-100M (a device creating electric fields to disrupt cancer cells). The goal is to see if this combo works better than current methods.See study design
What are the potential side effects?
Possible side effects include typical reactions from immunotherapy such as fatigue, skin reactions, inflammation in organs; from radiosurgery like headaches or scalp irritation; and from NovoTTF-100M like mild skin irritation under electrode areas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor outside of my brain that can be measured.
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I am mostly active and can care for myself.
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My hemoglobin level is at least 9 g/dL without needing transfusions or EPO recently.
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I have been diagnosed with malignant melanoma.
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My diagnosis is melanoma confirmed by tissue analysis.
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I am 22 years old or older.
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 moreTrial 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
~4750
Pembrolizumab
2017
Completed Phase 2
~2010
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Tumor Treating Fields Therapy
2018
Completed Early Phase 1
~30
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,722 Total Patients Enrolled
3 Trials studying Melanoma
42 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,123 Total Patients Enrolled
557 Trials studying Melanoma
193,180 Patients Enrolled for Melanoma
Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,636 Total Patients Enrolled
7 Trials studying Melanoma
147 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have signs of high pressure inside your head.I haven't had cancer treatment in the last 2 weeks or I've recovered from its side effects.I have only received the flu shot, not the nasal spray vaccine.I have a pacemaker, defibrillator, or brain stimulator, or significant heart rhythm problems.I haven't had immunotherapy, or if I did, it was approved by the study leader due to limited disease progression.You have a current infection of hepatitis B or C.I am using two birth control methods or am not having sex to join this study.I have been diagnosed with HIV.I have an active tuberculosis infection.I cannot have an MRI for treatment planning or follow-up.My cancer has spread to the brain stem.I have a tumor outside of my brain that can be measured.I practice abstinence as my form of birth control.I have 1-10 untreated brain tumors and may have had surgery for diagnosis or treatment.I experience nausea or vomiting due to increased pressure in my brain.I have fully recovered from any major surgery before starting treatment.I agree to use contraception during and for 4 months after immunotherapy.I am currently being treated for an infection.I have not received a live vaccine in the last 30 days.I have mild to moderate nerve damage.Your brain has shifted more than 5 millimeters from its normal position.I haven't been in a drug/device trial or taken immunosuppressives recently.I am eligible for immunotherapy and can have TTFields treatment with specific SRS procedures.You need to have blood tests done within 28 days before joining the study to make sure your health is normal.Your platelet count is at least 100,000 per microliter within the last 28 days before starting the treatment.I am not showing symptoms and have been on a low dose of steroids for at least 7 days.I have a decreased level of alertness due to increased pressure in my brain.I am mostly active and can care for myself.My kidney function tests are within the required range.Your liver enzymes (AST and ALT) should not be too high. If you have liver cancer that has spread, the levels should not be too high either.I am eligible for a short course of radiation therapy.My blood clotting time is normal or managed with medication.You are allergic to the hydrogel used for the treatment.My hemoglobin level is at least 9 g/dL without needing transfusions or EPO recently.I have been diagnosed with malignant melanoma.You have an implanted electrical device, except for an externally worn TTField device.I am not on high doses of steroids or other drugs that weaken my immune system.You have an allergy to the gel used for ECG or nerve stimulation.Your bilirubin levels in your blood are not too high.My diagnosis is melanoma confirmed by tissue analysis.I have had pneumonitis treated with steroids but am currently on 20 mg or less of prednisone.I have another cancer besides skin or in situ cervical cancer that is getting worse or needs treatment.I have had radiation for melanoma.I have been diagnosed with severe swelling of the optic nerve.Your blood test shows that you have enough infection-fighting white blood cells.I have had 14 days to recover from any previous cancer treatments before joining this study.I am 22 years old or older.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My melanoma is in the eye, mucous membranes, or of unknown origin.My blood clotting time is normal or managed if I'm on blood thinners.Your albumin level is at least 2.5 mg/dL within the last 28 days before starting the treatment.You are allergic to pembrolizumab or ipilimumab.
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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