Combining Targeted Radiation and Immunotherapy for Metastatic Uveal Melanoma
A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma
In Plain English
This trial tests a new combination approach for uveal melanoma that has spread to other parts of your body (usually the liver). You'll receive two treatments working together: focused radiation therapy that targets 1 to 5 specific tumors, and an immunotherapy drug called Opdualag that helps your immune system fight cancer cells throughout your body. The radiation is delivered in three quick doses over about a week, while the immunotherapy is given as an injection every 4 weeks for up to 2 years. The idea behind combining these treatments is that the radiation can help 'wake up' your immune system in the tumor area, making the immunotherapy work better. Right now, there's no standard treatment that works well for uveal melanoma that has spread, so this trial is exploring whether this combination might help more patients. Researchers will watch carefully for side effects and measure how well the tumors respond to treatment.
What This Trial Does
This is a trial of concurrent stereotactic radiation therapy (SBRT) with 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
How It Works
uveal melanoma has no standard therapy, but there is evidence that both radiation therapy and may be helpful and may be synergistic. This is a trial of concurrent stereotactic radiation therapy (SBRT) with 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.
Who Can Join
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
Treatments
stereotactic body radiotherapy (RADIATION)
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
Immunotherapy (DRUG)
Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years
Trial Sites (1)
California Pacific Medical Center Research Institute
San Francisco, California, United States
Madeline Decker · KimB@sutterhealth.org
Recruiting