Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216938
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-01-11
Brief Title:
RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Sponsor:
Yana Najjar
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Pilot Study of RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The majority of the almost 80000 patients newly diagnosed with melanoma each year in the US present with localized early-stage melanoma ie clinical stage III Per the standard of care SOC these patients are treated with a curative intent including wide local excision WLE with additional sentinel lymph node SLN biopsy SLNB for patients with Breslow 08 mm or 08 mm with ulceration or a positive deep margin The incidence of SLN metastases significantly increases with the Breslow thickness of the tumor and the presence of ulceration For T3b Breslow 2 mm with ulceration the incidence of SLN metastases is 23-42 For T4b disease Breslow 4 mm this increases up to 63 As the tumor draining lymph node TDLN the SLN is where naïve T cells are first primed However this is also the site where melanoma cells initiate tumor mediated immune suppression and form the pre-metastatic niche Thus the SLN is a key potential target for local immune therapeutic intervention in early-stage melanoma patients whereby tumor-mediated immune suppression can be counteracted and the antitumor immune response can be boosted As SLN positivity is the single most important prognostic factor in early-stage melanoma intervention at the SLN may prevent disease recurrence Almost all patients diagnosed with melanoma will have already undergone a diagnostic biopsy by the time they are seen by medical oncology The majority undergo shave biopsy by dermatology or their primary care physician and a smaller proportion have undergone punch or excisional biopsy Replimune is developing vusolimogene oderparepvec RP1 an oncolytic immunotherapy RP1 is a selectively replicating competent herpes simplex virus 1 HSV-1 that expresses exogenous genes and is administered by intratumoral injection Local delivery of RP1 following initial biopsy of primary melanoma prior to SLNB provides a unique setting to clinically assess the role of the TDLN in the biological efficacy of RP1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None