Purpose of this Study
We are doing this study to find out if an experimental drug called RP2 (the study drug) is a safe and effective option for people who have uveal melanoma (melanoma in the eye). We want to know how well the study drug works when it is combined with a drug called nivolumab, and we will compare its outcomes to treatment with the drug combination of nivolumab + ipilimumab.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with uveal melanoma
- Have disease that has spread to other parts of the body
- Have not been treated with immune checkpoint inhibitor therapy since their diagnosis
- Have at least 1 tumor that is large enough to take an injection
- Have never been treated with an oncolytic virus (a virus that has been changed to target cancer cells)
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study and are found to be eligible, you will get a random assignment (fair, equal chance) to 1 of 2 groups. You have a 50% chance of being assigned to either group. You will either:
- Get the study drug (an injection into the tumor) and nivolumab (an IV through a vein in your arm) every 3 weeks; OR
- Get ipilimumab and nivolumab (both are IVs through a vein in your arm) every 3 weeks
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
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
Principal Investigator
April
Salama
Protocol Number
PRO00116221
NCT ID
NCT06581406
Phase
II/III
Enrollment Status
Open to Enrollment