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 (NCT06581406)

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. This study investigates the Genetically Modified Organism (GMO) RP2.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Mark Shackleton

Key inclusion data

Have 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 safe serial injections of RP2 and to serial radiographic measurement and that has not been previously treated by surgery, irradiation, ablation, embolization, sclerosis, or any other lesion- directed or regional therapy. Have a life expectancy of > 3 months as estimated by the Investigator (PA1). Have a LDH ≤ 2 × upper limit of normal (ULN) based on central laboratory testing. Have an ECOG 0 to 1. Have a prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio [INR] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.