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

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

Trial Details

NCT ID
NCT06216938
Phase
EARLY_PHASE1
Sponsor
Yana Najjar
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Vusolimogene oderparepvec (RP1)
Locations (sample)
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589

Key Eligibility Criteria

  • Be willing and able to provide written informed consent for the trial.
  • Be ≥ 18 years of age on day of signing informed consent.
  • 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…
  • Females of childbearing potential must have a negative beta-human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU/L or equi…

For full eligibility, visit ClinicalTrials.gov.

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