A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma
Who is this study for? Patients with metastatic uveal melanoma
What treatments are being studied? Stereotactic body radiotherapy+Immunotherapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
California Pacific Medical Center Research Institute
RECRUITING
San Francisco
Contact Information
Primary
Madeline Decker
KimKB@sutterhealth.org
4156006000
Time Frame
Start Date: 2021-09-20
Estimated Completion Date: 2026-03
Participants
Target number of participants: 40
Treatments
Experimental: one arm
see below
Related Therapeutic Areas
Sponsors
Leads: California Pacific Medical Center Research Institute