A Phase 2-3 Study of Nivolumab With RP2 or Ipilimumab Immunotherapy in People With Uveal Melanoma

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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

Purpose

Researchers are comparing two different combination immunotherapies for uveal melanoma. The people in this study have uveal melanoma that has metastasized (spread).

If you take part in this study, you will be randomly assigned to get one of these treatments:

  • Nivolumab plus RP2
  • Nivolumab plus ipilimumab

RP2 is a virus that has been changed in the laboratory to grow in and destroy cancer cells. It is designed to turn on the immune system to attack cancer cells. RP2 is given as an injection into the tumor.

Nivolumab and ipilimumab both boost the power of the immune system to find and destroy cancer cells. They each take the brakes off the immune response, but in different ways. They are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic uveal melanoma that cannot be surgically removed.
  • Not have had prior immunotherapy for uveal melanoma nor liver-directed chemotherapy with melphalan.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Alexander Shoushtari’s office at 646-888-4161.

Protocol

25-082

Phase

Phase II/III (phases 2 and 3 combined)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Co-Investigators

ClinicalTrials.gov ID

NCT06581406