drugset / Trial / NCT07862530

Neoadjuvant RP2 + Nivolumab in Patients With Melanoma

NCT07862530 ↗

Phase 2 Not yet recruiting 34 enrolled Yana Najjar Replimune, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase II study is being done to determine whether a new combination of therapies is safe and effective for adults to treat Melanoma before surgery. The two therapies that will be combined in this study are nivolumab and RP2. Nivolumab is a standard treatment for this type of cancer. Nivolumab targets and blocks a receptor called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 may activate T-cells to find and kill cancer cells. RP2 is a new treatment that is not yet FDA approved to treat this cancer. RP2 is a herpes simplex virus (a microscopic life form commonly known as the "cold sore virus") that has been changed in the laboratory to grow in and destroy cancer cells and to activate (turn on) the immune system to attack the cancer cells.

Timeline

Start
2026-12-31
Primary completion
2028-02-27
Completion
2033-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Subject RP2 Other / unclassified — Other

Indications