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

California Pacific Medical Center Research Institute

Status and phase: Enrolling; Phase 2

Conditions: Uveal Melanoma

Treatments: Radiation: stereotactic body radiotherapy; Drug: Immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05077280

2021.072-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

one arm

Experimental group

Description:

see below

Treatment:

Drug: Immunotherapy

Radiation: stereotactic body radiotherapy