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NCT05341349 · ClinicalTrials.gov registry record · Phase 1
Stereotactic Radiosurgery and Immune Checkpoint Inhibitors With NovoTTF-200M for the Treatment of Melanoma Brain Metastases
A Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, sponsored by Emory University.
- Active
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
- 1
- Study location
NCT05341349: Active Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, sponsored by Emory University.
NCT05341349 is a Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain that is active but no longer recruiting, run by Emory University. The registered enrollment target is 1 participants, below the 84-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05341349, a Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Will be analyzed separately for arms 1 and 2. Radiation Therapy Oncology Group Grade 3 CNS toxicity will be measured using RTOG grade 3 CNS toxicity and reported as percentage of patients developing grad 3 CNS toxicity. Higher score means more patients developing toxicity. Lower score means less patients developing toxicity.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Nivolumab
- RADIATION Stereotactic Radiosurgery
- BIOLOGICAL Ipilimumab
- PROCEDURE Tumor Treating Fields Therapy
Study Locations (1)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2022-10-13 |
| Est. Completion | 2027-03-06 |
| Phase | Phase 1 |
What the registry record for NCT05341349 still lists
NCT05341349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 84-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (99% lower).
The record links to 7 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05341349 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05341349 about?
NCT05341349 is a clinical study titled "Stereotactic Radiosurgery and Immune Checkpoint Inhibitors With NovoTTF-200M for the Treatment of Melanoma Brain Metastases". 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 use...
What is the current status of trial NCT05341349?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2022-10-13. Estimated completion is 2027-03-06.
What conditions does trial NCT05341349 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Metastatic Malignant Neoplasm in the Brain, Clinical Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Metastatic Mucosal Melanoma.
What interventions are being tested in trial NCT05341349?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Nivolumab (BIOLOGICAL), Stereotactic Radiosurgery (RADIATION), Ipilimumab (BIOLOGICAL), Tumor Treating Fields Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT05341349?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05341349 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05341349's enrollment target sits among peer trials
1 92nd of 91 the lowest of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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