Yana Najjar
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.
This single-arm Phase II study will evaluate the safety and efficacy of neoadjuvant RP2 in combination with nivolumab in adults with resectable advanced melanoma. Participants will receive RP2 and nivolumab prior to surgery, followed by adjuvant nivolumab after surgery. The study will assess pathologic response at surgery, treatment-related toxicity, tumor response, recurrence-free survival, and overall survival. Exploratory analyses will evaluate changes in immune and tumor biomarkers associated with treatment response.
Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial. 2. Be ≥ 18 years of age on day of signing informed consent. 3. Cytologically or histologically confirmed resectable stage IIIB, IIIC, IIID, or IV melanoma of cutaneous or unknown primary origin with one or more macroscopic lymph node metastases (clinically detectable), that can be biopsied and a maximum of 3 additional resectable in-transit metastases. A concurrent resectable primary melanoma is allowed. Clinical detectable lymph nodes are defined as either a palpable node ora non-palpable but enlarg…
RP2 (vusolimogene oderparepvec) RP2 will be injected directly into the tumor every 2 weeks for three doses before surgery.
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.
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.
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