RecruitingPhase 2NCT05077280

A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma

A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma

Sponsor

California Pacific Medical Center Research Institute

Enrollment

40 participants

Start Date

Sep 20, 2021

Study Type

INTERVENTIONAL

Conditions

Uveal Melanoma

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of focused radiation (stereotactic body radiotherapy) alongside a newer immunotherapy drug called Opdualag (relatlimab + nivolumab) in people with metastatic uveal melanoma (a rare melanoma that originates in the eye). **You may be eligible if...** - You have measurable metastatic uveal melanoma - Your general health is good (performance status 0–1) - You are not on other cancer treatments currently - Your blood counts and organ function are adequate - You have not previously received Opdualag or relatlimab **You may NOT be eligible if...** - More than 50% of your liver is occupied by tumors - You have active brain metastases - You are pregnant - You have active hepatitis B, HIV, or certain autoimmune diseases - You have had prior liver embolization or radiation - You are on systemic steroids Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONstereotactic body radiotherapy

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

DRUGImmunotherapy

Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years

Locations(1)

California Pacific Medical Center Research Institute

San Francisco, California, United States

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NCT05077280

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