The study is currently in Phase 2 and is for patients with a diagnosis of unresectable metastatic uveal melanoma who have not been treated prior with Immune check point inhibitor therapy.

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.

Key Elgibility Criteria

You may be eligible for this study if you meet the following conditions (note, full eligibility and exclusion criteria is available at clinicaltrials.gov):

• Are capable of giving signed informed consent which includes willingness to comply with the requirements and restrictions listed in the informed consent form.
• 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.
• No exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma.
• LDH ≤ 2 × upper limit of normal (ULN).
• Has adequate hematologic, hepatic and renal function
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
• Life expectancy of > 6 months as estimated by the Investigator.

What to expect during the study

The study has three different phases. They are:

• Screening: Up to 28 days
• Treatment Period: Up to approximately 2 years
• Follow-up Period: Up to 3 years after treatment is completed

After the screening phase is completed, patients meeting all the inclusion criteria will be randomized into 1 of 2 treatment groups: RP2 + nivolumab or ipilimumab + nivolumab, which is an approved standard treatment for advanced melanoma.

Dosing of RP2 will start on Day 1 and will be administered directly into the tumor every 2 weeks for up to 8 cycles (approximately 4 months). After the first dose of RP2, dosing will be given with concurrent nivolumab infusion every 2 weeks up to 8 cycles and followed by either 2 weeks or 4 weeks dosing for up to an additional 20 months. Antitumor activity will be based on radiological and/or clinical evaluation and all patients will be assessed at Screening and once every 12 weeks.

IMPORTANT: Only your doctor can determine whether or not you are eligible to participate in this clinical study. Please note that if you decide to participate in the study, you can also choose to stop at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.