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Neoadjuvant RP2 + Nivolumab in Patients With Melanoma

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Yana Najjar
6 trials monitored
See 1 trial at risk
Melanoma
1,026 trials monitored
See 48 trials at risk
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.
Trial Details
NCT Number NCT07862530
Lead Sponsor Yana Najjar
Collaborators: Replimune, Inc.
Conditions MelanomaCutaneous Melanoma Resectable, Melanoma
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov