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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
View on ClinicalTrials.gov ↗
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. See every version on ClinicalTrials.gov ↗

2024-02-29
Status change Not Yet RecruitingRecruitingv1
Trial Details
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