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Checkpoint Inhibitor

Combination Therapy for Melanoma Brain Metastases

Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Targeting 7 different conditionsTumor Treating Fields Therapy +4 morePhase 1RecruitingLed by Mohammad K Khan, MD, PhDResearch Sponsored by Emory University

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 below
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 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 been diagnosed with malignant melanoma.
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.
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.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from srs to death, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from srs to death, assessed up to 2 years for reporting.

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 more

Awards & 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Completed Phase 3
Stereotactic Radiosurgery
Completed Phase 2
Completed Phase 3

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

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05341349 — Phase 1
Melanoma Research Study Groups: Arm I (SRS, pembrolizumab, TTFields), Arm II (nivolumab, ipilimumab, SRS, TTFields)
Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05341349 — Phase 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05341349 — Phase 1

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
~2 spots leftby Mar 2024