Tumor Treating Fields Therapy for Metastatic Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Metastatic Melanoma+10 More
Tumor Treating Fields Therapy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase I trial finds out the side effects and possible benefits of stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M for the treating of melanoma that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. It is used to treat brain tumors and other brain disorders that cannot be treated by regular surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. NovoTTF-100M is a portable battery operated device which produces tumor treating fields in the body by means of surface electrodes placed on the skin. Tumor treating fields are low intensity, intermediate frequency electric fields that pulse through the skin to disrupt cancer cells' ability to divide. Giving stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M may work better than stereotactic radiosurgery and immune checkpoint inhibitors.

Eligible Conditions

  • Metastatic Melanoma
  • Cutaneous Melanoma
  • Melanoma of Unknown Primary
  • Brain
  • Metastatic Mucosal Melanoma
  • Metastatic Ocular Melanoma
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metastatic Melanoma

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: From SRS to death, assessed up to 2 years

At 3 months
Incidence of grade 3 central nervous system (CNS) toxicity
The percentage of patients developing grade 3 CNS toxicity
Month 3
Rates of alopecia
Rates of skin toxicity
Month 12
Intracranial control
Time to progression
Year 2
Overall survival (OS)
Year 2
Progression free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Other trials for Metastatic Melanoma

Trial Design

2 Treatment Groups

Arm II (nivolumab, ipilimumab, SRS, TTFields)
1 of 2
Arm I (SRS, pembrolizumab, TTFields)
1 of 2
Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: Tumor Treating Fields Therapy · No Placebo Group · Phase 1

Arm II (nivolumab, ipilimumab, SRS, TTFields)Experimental Group · 4 Interventions: Stereotactic Radiosurgery, Tumor Treating Fields Therapy, Nivolumab, Ipilimumab · Intervention Types: Radiation, Procedure, Biological, Biological
Arm I (SRS, pembrolizumab, TTFields)Experimental Group · 3 Interventions: Stereotactic Radiosurgery, Tumor Treating Fields Therapy, Pembrolizumab · Intervention Types: Radiation, Procedure, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2012
Completed Phase 2
~320
Pembrolizumab
2017
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~5540
Ipilimumab
2014
Completed Phase 3
~3350

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from srs to death, assessed up to 2 years
Closest Location: Emory University Hospital/Winship Cancer Institute · Atlanta, GA
Photo of Atlanta 1Photo of Atlanta 2Photo of Atlanta 3
2013First Recorded Clinical Trial
5 TrialsResearching Metastatic Melanoma
49 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,450 Total Patients Enrolled
84 Trials studying Metastatic Melanoma
4,398 Patients Enrolled for Metastatic Melanoma
NovoCure Ltd.Industry Sponsor
52 Previous Clinical Trials
4,536 Total Patients Enrolled
1 Trials studying Metastatic Melanoma
30 Patients Enrolled for Metastatic Melanoma
Emory UniversityLead Sponsor
1,494 Previous Clinical Trials
2,665,953 Total Patients Enrolled
1 Trials studying Metastatic Melanoma
27 Patients Enrolled for Metastatic Melanoma
Mohammad K Khan, MD, PhDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
1 Previous Clinical Trials
52 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 22 years of age or older.
You are asymptomatic at time of getting SRS (day 0) on trial.
You are eligible for hypofractionation approach.
You have 1-10 untreated brain metastases at time of initial brain metastases diagnosis (surgery to at least one of the brain lesions and/or biopsy of a lesion for diagnostic purposes and/or for standard of care purposes is acceptable)

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.