Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599619
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on AtypicalDysplastic Nevi
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Study of the Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Features of AtypicalDysplastic Nevi in Patients with Stage IIB-IIIC Melanoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 study will examine the impact of anti-programmed cell death 1 PD1 therapy given in the approved adjuvant therapeutic regimens upon the morphologic histopathologic molecular and immunologic as well as genomic features of atypicaldysplastic nevi ADN in patients with a prior documented melanoma of Stages IIB IIC IIIA IIIB or IIIC and concurrent presence of four or more atypical nevi
Detailed Description:
Given the established efficacy of anti-PD1 therapy as an adjuvant treatment in both advanced nodal and earlier stage deep primary node negative melanoma this study hypothesizes that anti-PD1 therapy may provide a basis for effective therapeutic prevention To study if anti-PD1 therapy can help prevent the development of melanoma this study will examine its effects upon atypicaldysplastic nevi which are well established as non-obligate pre-cursor lesions that are markers of increased risk of melanoma This study will evaluate the impact of adjuvant anti-PD1 therapy on morphology histopathology immunologicmolecular features and gene expression of atypicaldysplastic nevi present in patients with stage IIB-III melanoma This study aims to determine if anti-PD1 therapy will increase CD8 T cell responses to melanoma antigens resulting in immune surveillance and anti-tumor immune responses within ADN It postulates that in response to anti-PD1 therapy the aggregate pigmentation of total nevi including atypicaldysplastic nevi and benign melanocytic nevi will decrease with a measurable morphologic response This study also asserts that there will be histopathologic changes within ADN including increased density of immune infiltrate and increased presence of regression features Increased anti-tumor immune response measured by increased CD8 IFN-y and PD-1 expression within nevi is anticipated along with a decrease in genes involved in pathways of melanomagenesis pigmentation and inflammation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None