A Study of Concurrent Stereotactic Body Radiotherapy With Ipi and Nivo in Metastatic Uveal Melanoma

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with ipilimumab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Ipilimumab will be given at 1mg/kg q 6 weeks for 12 doses, and nivolumab will be given 360mg every 3 weeks for 2-3 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Pacific Medical Center Research Institute

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 ipilimumab or other CTLA-4 inhibitor.

• Certain autoimmune diseases.

• Previous liver embolization or radiation.

• Use of systemic steroids