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NCT06216938Recruiting

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

Phase I Pilot Study of RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Yana NajjarPhase 1ClinicalTrials.govbiological
Study focus
Disease/Condition
Melanoma
Drug/Device/Intervention
Vusolimogene oderparepvec (RP1)
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Yana Najjar
Funder
University of Pittsburgh
Location
Pittsburgh, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Feb 02, 2024
End date
Jul 31, 2028
Enrollment
25 participants
Primary outcome

Rate of Sentinel Lymph Node (SLN) Positivity

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.

ICD-10 classifications
Malignant melanoma of skinMelanoma in situ, unspecifiedMelanoma in situMelanoma and other malignant neoplasms of skinMalignant neoplasm: Malignant melanoma of skin, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06216938
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06216938 through Pure Global AI's free database. This Phase 1 trial is sponsored by Yana Najjar and is currently Recruiting. The study focuses on Melanoma. Target enrollment is 25 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.