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

Launched by CALIFORNIA PACIFIC MEDICAL CENTER RESEARCH INSTITUTE · Oct 5, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with metastatic uveal melanoma, which is a type of eye cancer that has spread to other parts of the body. The study is testing the combination of a specialized form of radiation therapy called stereotactic body radiotherapy (SBRT) and a type of immunotherapy known as Opdualag, which includes two medications, nivolumab and relatlimab. Participants in the trial will receive three doses of radiation to target 1 to 5 tumor spots, along with the immunotherapy treatment every four weeks for up to two years.

To be eligible for this trial, participants should have measurable metastatic uveal melanoma and meet certain health criteria, such as having a good performance status (meaning they can carry out daily activities) and specific blood test results. People with certain conditions, like active liver tumors or ongoing autoimmune diseases, as well as pregnant individuals, cannot join the study. For those who qualify, the trial offers a chance to receive a potentially beneficial treatment combination that is still being evaluated for its effectiveness and safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • measurable metastatic uveal melanoma.
• • No concomitant therapy.
• • Prior PD1 or tebendafesp allowed.
• • Performance status 0-1.
• • No active Hepatitis B.
• • No known HIV infection.
• • WBC\>2000, ANC\>1500, Hgb \>8.
• • Creatinine \< 3 x ULN.
• • AST \& ALT \< 2.5 x ULN Bilirubin \< 2 x ULN.
• • Albumin \>2.9
• Exclusion Criteria:
• • Liver tumor volume \> 50%.
• • Active CNS metastases.
• • Pregnancy.
• • Prior therapy with Opdualag or relatlimab
• • Certain autoimmune diseases.
• • Previous liver embolization or radiation.
• • Use of systemic steroids