Title
A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination with Nivolumab versus Ipilimumab in Combination with Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients with Metastatic Uveal Melanoma

Description
A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

Objective
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.

Treatment Primary:
To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on overall survival (OS)
To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on progression free survival (PFS)
To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on overall response rate (ORR)
To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on duration of responses (DOR)
To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on disease control rate (DCR)
To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on clinical benefit rate (CBR)
To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on duration of clinical benefit (DOCB)
To characterize the safety profiles of patients treated with RP2 + nivolumab to patients with ipilimumab + nivolumab
To compare the incidence of immune mediated TEAEs (imAEs) in patients treated with RP2 + nivolumab relative to ipilimumab + nivolumab

Key Eligibility Key Inclusion Criteria:

Patients who are 18 years of age or older at the time of signed informed consent.

Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection.

Has at least 1 measurable and injectable tumor of ≥ 1 cm in longest diameter (>/= 1.5 cm in the shortest axis for a lymph node [LN]) that is amenable to serial RP2 injections.

Must be willing to provide tumor biopsy samples.

LDH
Has adequate hematologic, hepatic and renal function

Prothrombin time (PT)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Life expectancy of > 6 months as estimated by the Investigator.

Applicable Disease Sites
Melanoma/Skin cancer

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital