The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody
Nivolumab: Anti-PD-1 Monoclonal antibody
Overall Survival (OS)
OS is the time from the date of randomization to death from any cause.
Time frame: From Day 1 up to 3 years after last dose.
Progression Free Survival (PFS)
PFS is the time from randomization to first evidence of confirmed disease progression as assessed by BICR per RECIST 1.1 or death from any cause.
Time frame: From Day 1 up to 3 years after last dose.
Number of patients with treatment-emergent adverse events (TEAEs)
The incidence of all TEAEs.
Time frame: From first dose up to 100 days after last dose.
Overall Response Rate (ORR)
ORR is the proportion of patients with a confirmed best overall response of complete response (CR) or partial response (PR), as assessed by BICR per RECIST v1.1.
Time frame: Every 12 weeks from Day 1 up to 3 years after last dose.
Disease Control Rate (DCR)
DCR is the proportion of patients with a confirmed best overall response of CR, PR, or Stable Disease (SD), as assessed by BICR per RECIST 1.1.
Time frame: Every 12 weeks from Day 1 up to 3 years after last dose.
Giuseppe Gullo, MD
CONTACT
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