Newly Diagnosed Melanoma Metastases in the Brain and Spine Clinical Trial
Official title:
A Pilot Study of Stereotactic Radiosurgery Combined With Ipilimumab in Patients With Newly Diagnosed Melanoma Metastases in the Brain and Spine
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment