This research is being done to look at the safety of using stereotactic radiosurgery (SRS) and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Standard of care uses both of these treatments but not together. By using them together, we expect better treatment of melanoma, but there might be an increase in side effects. "Ipilimumab" is approved by the Food and Drug Administration (FDA) for the treatment of melanoma that has spread throughout the body. It works by activating your immune system to fight off cancer. "Stereotactic radiosurgery" (SRS) is approved by the Food and Drug Administration (FDA) for the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without needing to cut or use stitches. The use of combining SRS and Ipilimumab in this research study is investigational. The word "investigational" means that this combination is not approved for marketing by the Food and Drug Administration but is allowed for use in this research study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Number of adverse events and severity of the adverse events.
To assess the safety profile of stereotactic radiosurgery with ipilimumab in combination to treat patients with newly diagnosed melanoma brain or spinal metastases.
Time frame: 2 years
To estimate local control rate in brain and spine
To estimate systematic control rate; To estimate progression-free survival
Time frame: 1 years
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