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RP2 + Nivolumab for Melanoma

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Yana Najjar
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with melanoma (a type of skin cancer) who are eligible for surgery. Participants should be healthy enough for treatment and surgery. People with certain other health conditions or infections may not qualify.

Inclusion Criteria

Be willing and able to provide written informed consent for the trial
I am 18 years old or older.
My cancer has a BRAF V600E or V600K mutation.
See 9 more

Exclusion Criteria

I have not had major surgery in the past week, or I have fully recovered from it.
Solid organ transplant recipient
I do not have untreated hepatitis B, active hepatitis C, or uncontrolled HIV infection.
See 19 more

What Are the Treatments Tested in This Trial?

Interventions

  • Nivolumab
  • RP2 (vusolimogene oderparepvec)

Trial Overview

The study tests a combination of two treatments—RP2 (a modified virus that targets cancer cells) and nivolumab (an immune therapy)—given before surgical removal of melanoma, to see if this approach is safe and effective.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: RP2 + NivolumabExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yana Najjar

Lead Sponsor

Trials
7
Recruited
200+

Replimune, Inc.

Industry Sponsor

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