Neoadjuvant RP2 + Nivolumab in Patients With Melanoma

Conditions

• MelanomaCutaneous Melanoma Resectable, Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RP2 (vusolimogene oderparepvec) — DRUG
  RP2 (vusolimogene oderparepvec) RP2 will be injected directly into the tumor every 2 weeks for three doses before surgery.
• Nivolumab — DRUG
  Nivolumab will be administered by intravenous infusion at a dose of 240 mg every 2 weeks for 3 doses during the neoadjuvant period, followed by 480 mg every 4 weeks for 11 doses during the adjuvant period.
• Definitive Surgical Resection — PROCEDURE
  Participants will undergo definitive surgical resection of all clinically resectable melanoma lesions following completion of neoadjuvant treatment with RP2 and nivolumab. Surgery will be performed according to standard clinical practice and institutional guidelines. Resected tumor tissue and, where applicable, involved lymph nodes will be collected and evaluated for pathologic response and other study-related assessments.

Study Details

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.

Key Dates

First listed

Oct 7, 2026

Start date

Dec 31, 2026

Status verified

Sep 2026

Primary completion

Feb 27, 2028

Completion

Dec 31, 2033

Study Design

Enrollment

34 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: RP2 + Nivolumab
  RP2 + Nivolumab Followed by Surgery and Adjuvant Nivolumab

Primary Outcome Measure

Major Pathologic Response Rate (MPR) [ Time Frame: At the time of definitive surgery, approximately 8 to 10 weeks after initiation of neoadjuvant treatment. ]

Locations (1)

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