NCT06216938 · ClinicalTrials.gov record · last posted 2026-04-13
RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
StatusRecruiting
PhaseEarly Phase 1
Started2024-03-07
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from the ClinicalTrials.gov record
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.
Amendment record
3 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 3 times since 2024-01-11; most recent amendment 2026-04-07. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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2024-02-29
Status change Not Yet Recruiting→Recruitingv1
| NCT Number |
NCT06216938 |
| Lead Sponsor |
Yana Najjar
Collaborators: Replimune, Inc. |
| Conditions |
Melanoma |
| Enrollment |
25 participants |
| Start Date |
2024-03-07 |
| Primary Completion |
2028-03-31 (estimated) |
| Study Completion |
2029-03-31 (estimated) |
| Updated on ClinicalTrials.gov |
2026-04-13 |