Stereotactic Radiosurgery and Immune Checkpoint Inhibitors With NovoTTF-200M for the Treatment of… (NCT05341349) | Clinical Trial Compass
TerminatedPhase 1
Stereotactic Radiosurgery and Immune Checkpoint Inhibitors With NovoTTF-200M for the Treatment of Melanoma Brain Metastases
Stopped: Slow accrual
United States1 participantsStarted 2022-10-13
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be willing and able to provide written informed consent for the trial
* Have diagnosis of malignant melanoma.
* Be \>= 22 years of age on the day of signing informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 or Karnofsky performance status \>= 70%
* Patients must have histological diagnosis of melanoma
* Preference is for treatment naive patients that have not gotten previous immunotherapy. However, if approved by principal investigator (PI), patients that have gotten prior PD1 and/or dual immune checkpoint inhibitor therapy may be allowed on this trial if they have progressed intra-cranially or extra-cranially, and have very limited disease progression.
* 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
* Patients with ocular, mucosal and unknown primary melanoma will also be eligible
* Patients with 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). If patient has surgical removal of at least one lesion, the investigator would wait for a reasonable time after surgery to start the TTFields, SRS and Immunotherapy. This is typically around 2-4 weeks after resection and clearance by neurosurgery to start t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — can you help me understand what that might mean for the safety or usefulness of the data it collected, especially since it was a Phase 1 study focused on brain toxicity?
2Since the primary thing this trial was measuring was the rate of serious brain-related side effects (grade 3 CNS toxicity), does the fact that it's now terminated tell us anything about whether the combination of NovoTTF-200M, radiosurgery, and checkpoint inhibitors raised concerning safety signals?
3Given that this was a Phase 1 trial — meaning it was still in the earliest stage of testing safety in humans — and it's now been terminated, are there other active trials or standard treatment approaches for melanoma brain metastases that might be a better fit for my situation right now?
4My melanoma is in the brain, and this trial combined three different treatments at once — stereotactic radiosurgery, immune checkpoint inhibitors, and an electrical device called NovoTTF-200M — is wearing a device like that on a daily basis something that would realistically fit into my life, and are there alternatives that involve fewer simultaneous treatments?
5Since this trial is no longer enrolling, are any results or safety findings from it available that my care team could use to inform decisions about combining radiosurgery and immunotherapy for my melanoma brain metastases?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percentage of patients developing grade 3 CNS toxicity