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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one arm | Experimental | see below |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of the therapy | toxicity measured by CTAE graded 3-5 toxicities | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | iRECIST defined response rates | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | survival without progressive cancer | 5 years |
| Overall survival | survival | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madeline Decker | Contact | 4156006000 | KimKB@sutterhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| David R Minor, MD | California Pacific Med Center Research Inst. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center Research Institute | Recruiting | San Francisco | California | 94115 | United States |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Immunotherapy | Drug | Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years |
|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |