To evaluate the overall survival of HLA-A*0201 positive adult patients with previously
untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine,
ipilimumab, or pembrolizumab.
This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with
Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A*0201 positive adult
patients with advanced UM treated in the first line setting with no prior systemic or
liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior
surgical resection of liver metastases and adjuvant systemic therapy are acceptable).
Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the
concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall
survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective
response rate (ORR), duration of response (DOR), and disease control rate (DCR).