Phase I Pilot Study of RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Yana Najjar
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.
Description
The majority of the almost 80,000 patients newly diagnosed with melanoma each year in the U.S. present with localized early-stage melanoma (i.e., clinical stage I/II). Per the standard of care (SOC), these patients are treated with a curative intent, including wide local excision (WLE), with additional sentinel lymph node (SLN) biopsy (SLNB) for patients with Breslow ≥ 0.8 mm or \< 0.8 mm with ulceration or a positive deep margin. The incidence of SLN metastases significantly increases with the Breslow thickness of the tumor and the presence of ulceration. For T3b (Breslow \> 2 mm, with ulcera…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Have a diagnosis of pT3b, T4a or T4b melanoma on biopsy. Patients must have grossly visible residual tumor, or a positive deep or lateral margin on initial biopsy. Patients with uveal melanoma are not eligible. 4. Females of childbearing potential must have a negative beta-human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG during screening, before the first dose, and a negative uri…
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.
Location
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania