Uveal Melanoma
Conditions
Keywords
metastatic
Brief 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
Detailed description
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.
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
Sponsors
California Pacific Medical Center Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability of the therapy | 5 years | toxicity measured by CTAE graded 3-5 toxicities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 5 years | iRECIST defined response rates |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 5 years | survival without progressive cancer |
| Overall survival | 5 years | survival |
Countries
United States
Contacts
Primary ContactMadeline Decker
Outcome results
None listed