RecruitingEarly Phase 1NCT06216938

RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis

Phase I Pilot Study of RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis

Sponsor

Yana Najjar

Enrollment

25 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

Melanoma

Summary

This early-phase study will examine Vusolimogene Oderparepvec, a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities. Upon administration, vusolimogene oderparepvec specifically targets, infects and replicates in tumor cells and does not infect healthy cells. This results in tumor cell lysis and the release of virus particles which infect and replicate within nearby tumor cells, resulting in tumor cel death. The immune system is activated by the released tumor-associated antigens (TAAs) from the tumor cells creating an anti-tumor immune response against the tumor cells, thereby further killing the tumor cells. The virus itself also elicits a tumor-specific systemic immune and cytotoxic T-lymphocyte (CTL) response, thereby killing nearby non-infected tumor cells.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an experimental virus-based treatment called RP1 (injected directly into the tumor) in people with thick or deeply invasive melanoma skin cancer, to see if it can reduce the chance that cancer will spread to nearby lymph nodes before surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a thick or advanced melanoma (stage T3b, T4a, or T4b) with visible remaining tumor or unclear margins after biopsy - You are generally healthy and able to carry out daily activities (ECOG 0–1) - You are willing to use effective contraception during and for 90 days after treatment **You may NOT be eligible if...** - You have previously received an oncolytic (virus-based) cancer therapy - You have active or chronic hepatitis B, hepatitis C, or HIV infection - You have a serious active herpes infection or history of herpes complications (e.g., eye or brain involvement) - You had major surgery within the past week - You need high-dose corticosteroids (more than 10 mg prednisone daily) - You have had a live vaccine in the last 30 days - You have an eye melanoma (uveal melanoma) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVusolimogene oderparepvec (RP1)

Vusolimogene Oderparepvec is a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities.