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

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 31, 2026 to Mar 31, 2028 Completion date: Mar 31, 2027 to Mar 31, 2029v4 Show 1 more changeShow less
    • Completion date: Mar 31, 2027 to Mar 31, 2029
  2. Start date: Feb 2, 2024 to Mar 7, 2024 Primary completion date: Jan 31, 2026 to Mar 31, 2026 · Completion date: Jul 31, 2028 to Mar 31, 2027v3 Show 2 more changesShow less
    • Primary completion date: Jan 31, 2026 to Mar 31, 2026
    • Completion date: Jul 31, 2028 to Mar 31, 2027
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 31, 2024 to Feb 2, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jan 31, 2024 to Feb 2, 2024
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Yana Najjar
6 trials monitored
See 1 trial at risk
Melanoma
1,026 trials monitored
See 48 trials at risk
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.
Trial Details
NCT Number NCT06216938
Lead Sponsor Yana Najjar
Collaborators: Replimune, Inc.
Conditions Melanoma
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov