Replimune RP2-202 (Uveal Melanoma) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Metastatic Uveal Melanoma

Who Can Participate in the Study?

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)

For more information, contact the study team at emily.bolch@duke.edu.

Grupo etario
Adultos

What is Involved?

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

You will have tumor measurements every 12 weeks. You will receive treatment for up to 24 months, unless you have unwanted side effects or the study doctor finds that you are not getting better.

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
Especialista en oncología médica
Protocol Number
IRB: PRO00116221
NCT: NCT06581406
Phase
Phase II/III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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