Background: Overall survival (OS) of MUM pts remains poor (median 12 months), stressing the lack of effective therapies in this rare cancer. Targeting angiogenesis seems to be promising in uveal melanoma (UM). Antiangiogenic agents are used to treat neovascular ocular diseases such as age-related macular degeneration or proliferative diabetic retinopathy. B suppressed in vitro growth and in vivo hepatic establishment of micrometastases in experimental UM. Preclinical data suggest a potential clinical benefit of the combination of dacarbazine and B. Methods: Two-stage phase II trial; expected 6-month progression-free rate (PFR) of 40% with BEVATEM versus 15% with chemotherapy (power 94%, α risk 3%). Primary endpoint: 6-month PFR according to RECIST. Secondary objectives: response and survival rates, safety; liver perfusion CT for functional imaging of response; impact of VEGF-A gene polymorphisms on B pharmacodynamics. Treatment schedule: T 150mg/m2 d1-d7 and d15-d21 oral route, B 10 mg/kg d8 d22 IV infusion, 6 cycles (d1=d28) then B maintenance until toxicity or progression. Results: 35 evaluable pts have been enrolled from May 2010 to May 2012. First step analysis showed 3/17 first patients with disease control at 6 months and good tolerance. The final population consisted of 19 men and 16 women, median age 55 (29-72). PS was 0 in 28 and 1 in 7 pts, and the median time to metastasis was 38 months (17-62). Liver was the sole metastatic site in 29 pts.With an administered dose-intensity similar to the planned schedule, 7 and 9 pts experienced grade 3 (neutropenia 4, thrombocytopenia 1, constipation 1, pruritis 1) or grade 4 toxicities (neutropenia 3, thrombocytopenia 4, thrombosis 1) respectively. Despite no objective response, 9/35 pts showed stable disease, and the 6-month PFR was 26% [95%CI 13-41]. With a median follow-up of 18 months, 5 pts (14%) had long lasting non progressive disease with B maintenance (10+ to 29+ months). Finally, the median PFS and OS were 3 and 12 months respectively. Conclusions: BEVATEM regimen in first line MUM patients showed safety and 6-month PFR of 26% including 14% of pts with durable clinical benefit. Clinical trial information: 2009-011751-46.