This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with relatlimab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years
Metastatic uveal melanoma has no standard therapy, but there is evidence that both radiation therapy and immunotherapy may be helpful and may be synergistic. This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with Opdualag (nivolumab 480mg and relatlimab 160mg) for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases, limiting the total dosage to 700cc's of normal liver to \<15Gy. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years. Objectives are to determine the safety and tolerability, and iRECIST will be used to determine responses.We will treat up to 50 patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Stereotactic Body radiotherapy will be given to 1-5 target metastases in 3 doses over 8 days or less. Each dose will be 15Gy for a total dose of 45GY
Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years
California Pacific Medical Center Research Institute
San Francisco, California, United States
RECRUITINGsafety and tolerability of the therapy
toxicity measured by CTAE graded 3-5 toxicities
Time frame: 5 years
Response rate
iRECIST defined response rates
Time frame: 5 years
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