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RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis - Trial NCT06216938

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.

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NCT06216938
Phase 1
Recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06216938
View on ClinicalTrials.gov
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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

Study Focus

Melanoma

Vusolimogene oderparepvec (RP1)

Interventional

biological

Sponsor & Location

Yana Najjar

University of Pittsburgh

Pittsburgh, United States of America

Timeline & Enrollment

Phase 1

Feb 02, 2024

Jul 31, 2028

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 skin
Melanoma in situ, unspecified
Melanoma in situ
Melanoma and other malignant neoplasms of skin
Malignant neoplasm: Malignant melanoma of skin, unspecified

Data Source

ClinicalTrials.gov

NCT06216938

Non-Device Trial