An open-label study comparing RP2 with Nivolumab to Ipilimumab with Nivolumab to treat Melanoma
Research type
Research Study
Full 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
IRAS ID
1010945
Contact name
Kari Jeschke
Contact email
Sponsor organisation
Replimune, Inc.
Research summary
Uveal melanoma (UM) is a rare type of cancer that develops in the back of the eye. Unfortunately, it often spreads even if the original cancer is successfully treated, usually to the liver, after which the cancer is incurable and most people only live for a year or two. There are few treatment options, and those we have are only modestly beneficial, and often only work in a small proportion of patients.
RP2 is a new therapy that was developed from the cold sore virus (called herpes simplex virus), It has been engineered so that the virus can only infect and kill cancer cells, and it also releases proteins that make the immune system more active against the cancer. RP2 is injected directly into the cancer. In the case of UM this usually means injections into metastases in the liver which is done under imaging guidance (ultrasound or CT). In a previous trial, we found that about a third of patients with mUM treated with RP2 in combination with nivolumab in Study RP2-001-18 had good response to treatment which was often durable; and the treatment could be delivered safely and with manageable side effects.
In the current study (RP2-202) we will further evaluate the clinical benefits and safety of RP2 in combination with nivolumab (Test Arm) for the treatment of patients with mUM who have not had immune checkpoint inhibitor treatment before and where the cancer is not amendable to surgical resection. This Test Arm will be compared with combination of nivolumab and ipilimumab which is a commonly used treatment in normal clinical practice (control arm). Patients will be randomly allocated to one of the arms.
Approximately 280 adult patients will participate in the study. Treatment will continue until the disease worsens significantly, there is unacceptable side effects, withdrawal of consent, or for approximately 2 years, whichever occurs first. Patients will be monitored closely, as the treatment may have side side effects that are not yet known.REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0366
Date of REC Opinion
3 Jul 2025
REC opinion
Further Information Favourable Opinion